FDA Approval, Presentation and Treatment

FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD)

PLOS: DNA Science

MARCH 28, 2024

FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary. A gene-based treatment would have to alter many cells to exert a noticeable effect.

FDA Approval

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic.

The Pharma Data

OCTOBER 29, 2021

Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. The blessing of Scemblix may offer stopgap to cases by addressing gaps in CML care.” Scemblix nearly doubled the MMR ratevs.

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FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S.

FDA Approval

FDA Approval FDA Treatment Clinical Trials

Mesna Improves Outcomes of Sulfur Mustard Inhalation Toxicity in an Acute Rat Model [Drug Discovery and Translational Medicine]

ASPET

AUGUST 4, 2023

Sodium 2-mercaptoethane sulfonate (mesna) is an organosulfur compound that is currently FDA-approved for decreasing the toxicity of mustard-derived chemotherapeutic alkylating agents like ifosfamide and cyclophosphamide.

FDA Approval

FDA Approval FDA Drugs Treatment

Contrasting the Reinforcing Effects of the Novel Dopamine Transport Inhibitors JJC8-088 and JJC8-091 in Monkeys: Potential Translation to Medication Assisted Treatment [Behavioral Pharmacology]

ASPET

SEPTEMBER 20, 2024

Despite considerable efforts, there remains no FDA-approved medications for cocaine use disorder (CUD). The present studies evaluated the reinforcing effects of both compounds in monkeys under several conditions. One strategy to mitigate cocaine craving and relapse is to elevate dopamine (DA). mg/kg/injection), and JJC8-091 (0.1-3.0

FDA Approval

FDA Approval Treatment FDA Drugs

FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease

The Pharma Data

AUGUST 7, 2021

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. LOPD symptoms may present at any age.

FDA Approval

FDA Approval Disease FDA Treatment

Allergan, an AbbVie Company, to Present Data from its Leading Portfolio of Eye Care Treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting

The Pharma Data

FEBRUARY 24, 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. The XEN Gel Stent is FDA-cleared only for ab-interno placement.

Treatment

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Teva to Present Data

The Pharma Data

MAY 22, 2023

Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. once-monthly dosing) and 2.7

FDA Approval

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Regeneron Announces Investor Conference Presentations

The Pharma Data

OCTOBER 27, 2020

Cowen Virtual Presentation Series – 2020 IO Next Summit at 1:15 p.m. (NASDAQ: REGN ) will webcast management participation as follows: Credit Suisse 29 th Annual Virtual Healthcare Conference at 8:45 a.m. EST on Monday, November 9, 2020. EST on Friday, November 13, 2020. Jefferies Virtual London Healthcare Conference at 7:20 a.m.

FDA Approval

FDA Approval Laboratories Disease Pharmaceuticals

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

Therapies FDA FDA Approval Treatment

Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Oxidation of adagrasib occurs on the methylpyrrolidine group 4.

Small Molecule

Small Molecule FDA Approval FDA Drugs

Regeneron Announces Presentation at the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

DECEMBER 16, 2020

NASDAQ: REGN) will webcast its presentation at the 39 th Annual J.P. The presentation is scheduled for 8:20 a.m. TARRYTOWN, N.Y. , 16, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Morgan Healthcare Conference on Monday, January 11, 2021.

FDA Approval

FDA Approval Laboratories Disease Pharmaceuticals

Aurinia Pharmaceuticals to Present at the Piper Sandler 32nd Annual Virtual Healthcare Conference

The Pharma Data

DECEMBER 1, 2020

Presentations will be available for registered attendees via the Piper Sandler conference site through December 3. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc.

Pharmaceuticals

Pharmaceuticals FDA Approval FDA Therapies

Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)

The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Portfolio Highlights. Pipeline Highlights.

Research

Research Clinical Trials Trials FDA Approval

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [5] FDA prescribing information for fezolinetant. Health Sci Rep. 6(10):e1610.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

Aurinia Pharmaceuticals to Present at Two Upcoming Virtual Healthcare Conferences

The Pharma Data

JANUARY 7, 2021

The Company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (LN). The Company’s head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

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Pharmaceuticals FDA Approval Clinical Trials FDA

The science of ageing and restoring healthspan

Drug Target Review

JANUARY 8, 2024

Our lead program utilises OSK for the treatment of age-related optic neuropathies. Jerry has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development, and global commercialisation of more than a dozen FDA-approved drugs with multiple successful exits.

Science

Science Disease FDA Approval Clinical Trials

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development

Drug Development Treatment FDA Approval Drugs

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

Treatment

Treatment FDA Approval Pharmacokinetics FDA

AbbVie to Present Data From Its Migraine Portfolio at the.

The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

Doctors

Doctors Treatment Trials Clinical Trials

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

The Pharma Data

SEPTEMBER 2, 2020

New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence. Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations.

Clinical Trials

Clinical Trials Treatment Disease Therapies

Advancing CAR-T therapy: how CD5 modulation is shaping cancer treatment

Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. However, these treatments will eventually fail for the majority of patients, so there is a strong need for better CAR therapies.

Therapies

Therapies Treatment Engineering Molecular Biology

Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials

The Pharma Data

OCTOBER 21, 2020

a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. BRIDGEWATER, N.J.,

FDA Approval

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

JULY 8, 2021

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. ADUHELM is indicated for the treatment of Alzheimer’s disease.

Clinical Trials

Clinical Trials FDA Approval Trials FDA

U.S. FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine

The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

Treatment

Treatment FDA Doctors Drugs

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. The initiation of treatment requires no loading dose or oral supplementation.

FDA Approval

FDA Approval Treatment FDA Clinical Trials

New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis

The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data.

Treatment

Treatment Disease FDA Approval Clinical Trials

Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. “I About the Phase 1/2 Trial for HPN217.

Treatment

Treatment FDA Clinical Trials Trials

Data Presented at TCT Connect Finds Pre-PCI Use of Impella for AMI Cardiogenic Shock is Associated with Higher Survival, Particularly in Women

The Pharma Data

OCTOBER 15, 2020

The findings were presented at TCT Connect , the 32nd annual scientific symposium of the Cardiovascular Research Foundation. In the first study, presented by Hemindermeet Singh, MD, of Ascension St. m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID?19),

Hospitals

Hospitals FDA Approval FDA Treatment

llergan, an AbbVie Company, to Present New Data from its Leading Eye Care Portfolio at the 2021 ASCRS (American Society of Cataract and Refractive Surgery) Annual Meeting

The Pharma Data

JULY 21, 2021

– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Details about Allergan’s presentations are as follows: .

Treatment

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Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

The Pharma Data

APRIL 11, 2023

NYSE and TASE: TEVA),today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023. Additional abstracts from the Enroll-HD Global Registry and AJOVY ® (fremanezumab-vfrm) will also be presented.

FDA Approval

FDA Approval Disease Treatment FDA

Shifting Paradigms in PAH Clinical Trials: 7 Key Takeaways for Success

PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. RHC: Right heart catheterization presents various challenges that can be addressed through specific solutions.

Clinical Trials

Clinical Trials Trials Clinical Research Disease

Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

The Pharma Data

FEBRUARY 18, 2022

These data (Presentation #DOP44) will be presented at the 17 th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place February 16-19, 2022. Additional Bristol Myers Squibb-sponsored abstracts presented at the ECCO 2022 Congress can be accessed online here.

Clinical Trials

Clinical Trials Treatment Immune Response Disease

Neuroscience Portfolio at the 2021 American Academy of Neurology (AAN) Annual Meeting

The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below.

Clinical Trials

Clinical Trials Treatment Trials Disease

Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma

The Pharma Data

OCTOBER 27, 2021

The FDA has also granted precedence review to the company’s sBLA for Kymriah in adult cases with r/ r FL. Data from the trial was presented before this time as an oral donation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting.

FDA

FDA Treatment Trials FDA Approval

Regeneron Announces Investor Webcast at American Society of Hematology 2020 Annual Meeting

The Pharma Data

NOVEMBER 30, 2020

NASDAQ: REGN) will host a webcast on Monday, December 7, 2020 at 4:30pm EST. Management will discuss data presented at the American Society of Hematology (ASH) 2020 Annual Meeting as well as provide updates on the Company’s broader oncology and hematology portfolio. TARRYTOWN, N.Y. ,

FDA Approval

FDA Approval Laboratories Disease Pharmaceuticals

Successful Applications of Real-World Data and Real-World Evidence in Rare Disease Programs

The Premier Consulting Blog

OCTOBER 11, 2022

In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases. The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement.

Disease

Disease FDA FDA Approval Treatment

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

Clinical Trials

Clinical Trials Trials Treatment Pharmaceuticals

European Medicines Agency Validates Gilead’s Marketing Authorization Application for Lenacapavir,

The Pharma Data

AUGUST 19, 2021

. – If Authorized, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Twice Yearly –. These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections ( virtual CROI 2021).

Marketing

Marketing Treatment FDA FDA Approval

OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law Blog: Biosimilars

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Therefore, the presentation of these claims (i.e.,

FDA

FDA FDA Approval Treatment Drugs

Ocular Therapeutix Announces Receipt of a Permanent Category I CPT Code from the American Medical Association for the Insertion of Intracanalicular Inserts

The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. mg, effective January 1, 2022. About DEXTENZA.

Clinical Trials

Clinical Trials FDA Approval Treatment Production

Lilly’s donanemab receives U.S. FDA’s Breakthrough Therapy designation for treatment of Alzheimer’s disease

The Pharma Data

JUNE 28, 2021

The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

Therapies

Therapies Disease Treatment FDA Approval

Leveraging ADCs in precision oncology strategy

Drug Target Review

MAY 27, 2024

What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans? At a base-layer, Caris’ comprehensive molecular profiling that we perform for patients today can identify predictive biomarkers for current FDA-approved ADCs.

Clinical Trials

Clinical Trials Science Molecular Biology Bioinformatics

FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD)

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

Webinars

Trending Sources

FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic.

Webinars

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

Mesna Improves Outcomes of Sulfur Mustard Inhalation Toxicity in an Acute Rat Model [Drug Discovery and Translational Medicine]

Contrasting the Reinforcing Effects of the Novel Dopamine Transport Inhibitors JJC8-088 and JJC8-091 in Monkeys: Potential Translation to Medication Assisted Treatment [Behavioral Pharmacology]

FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease

Allergan, an AbbVie Company, to Present Data from its Leading Portfolio of Eye Care Treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting

Teva to Present Data

Regeneron Announces Investor Conference Presentations

What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

Metabolism of 2022 FDA approved small molecule drugs PART 2

Regeneron Announces Presentation at the 39th Annual J.P. Morgan Healthcare Conference

Aurinia Pharmaceuticals to Present at the Piper Sandler 32nd Annual Virtual Healthcare Conference

Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Aurinia Pharmaceuticals to Present at Two Upcoming Virtual Healthcare Conferences

The science of ageing and restoring healthspan

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

AbbVie to Present Data From Its Migraine Portfolio at the.

Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020

Advancing CAR-T therapy: how CD5 modulation is shaping cancer treatment

Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

U.S. FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis

Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma

Data Presented at TCT Connect Finds Pre-PCI Use of Impella for AMI Cardiogenic Shock is Associated with Higher Survival, Particularly in Women

llergan, an AbbVie Company, to Present New Data from its Leading Eye Care Portfolio at the 2021 ASCRS (American Society of Cataract and Refractive Surgery) Annual Meeting

Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

Shifting Paradigms in PAH Clinical Trials: 7 Key Takeaways for Success

Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

Neuroscience Portfolio at the 2021 American Academy of Neurology (AAN) Annual Meeting

Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma

Regeneron Announces Investor Webcast at American Society of Hematology 2020 Annual Meeting

Successful Applications of Real-World Data and Real-World Evidence in Rare Disease Programs

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

European Medicines Agency Validates Gilead’s Marketing Authorization Application for Lenacapavir,

OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

Ocular Therapeutix Announces Receipt of a Permanent Category I CPT Code from the American Medical Association for the Insertion of Intracanalicular Inserts

Lilly’s donanemab receives U.S. FDA’s Breakthrough Therapy designation for treatment of Alzheimer’s disease

Leveraging ADCs in precision oncology strategy

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