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.

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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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Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Conversations in Drug Development Trends

MAY 30, 2024

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials. Initial approval in 2022: FDA, U.S.

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Bridging Innovation & Patient Care: The Growing Role of AI

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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.

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FDA approves innovative treatment for pediatric patients with congenital athymia

The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. director of the FDA’s Center for Biologics Evaluation and Research. Today, the U.S. Dosing is patient?customized,

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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.

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FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. The approval of Oxlumo is a further testament to the impact RNAi therapeutics can have in transforming the treatment of severe, life-threatening diseases like PH1. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov.

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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

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The Long Road to End Tuberculosis

Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. tuberculosis ’ cellular architecture, however, presents an additional challenge for scientists developing new antibiotics. million people every year. tuberculosis.

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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.

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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.

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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

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Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Comenzo, M.D.,

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FDA Approves J&J’s Darzalex Faspro for Rare Light Chain Amyloidosis

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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FDA Approves Treatment for Rare Blood Disease

The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S.

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

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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

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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

Biologics: Innovations, Challenges, and the Road Ahead

DrugBank

MAY 6, 2024

Unlike conventional chemical-based medicines, biologics offer targeted therapies derived from living cells, which can result in more effective and personalized treatments. A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals.

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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. ENSPRYNG treatment is administered every four weeks after an initial loading dose. Basel, 17 August 2020.

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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

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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.

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Dentitox Pro – Text Presentation

The Pharma Data

MAY 15, 2021

Product Name: Dentitox Pro – Text Presentation. Click here to get Dentitox Pro – Text Presentation at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. Dentitox Pro is non-GMO and safe. Read more here.

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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

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U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

The Pharma Data

JULY 12, 2021

Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia ®. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th.

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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.

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FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer

The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. BASEL, Switzerland, Dec.

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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.

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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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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.

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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

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Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. In the U.S.,

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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.

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FIRST-LINE TREATMENT FOR ALK-POSITIVE METASTATIC LUNG CANCER

The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Treatment

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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.

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Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. million treatment courses of PAXLOVID have been prescribed in the U.S. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern.

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Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone.

The Pharma Data

SEPTEMBER 1, 2021

Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Click here to learn more: [link]. The Janssen U.S.

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Amgen Presents New Data From Thoracic Oncology Portfolio At WCLC21

The Pharma Data

SEPTEMBER 8, 2021

Amgen (NASDAQ: AMGN) today announced results from two analyses of the Phase 2 CodeBreaK 100 clinical trial evaluating LUMAKRAS™ (sotorasib), the first and only KRAS G12C inhibitor approved in the U.S., in the treatment of previously treated patients with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

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Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. Drug Enforcement Administration.

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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.

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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.,

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Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent of patients in the combination arm versus 56.2

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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

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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

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Webinars

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

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

FDA approves innovative treatment for pediatric patients with congenital athymia

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

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

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]

The Long Road to End Tuberculosis

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

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

FDA Approves J&J’s Darzalex Faspro for Rare Light Chain Amyloidosis

FDA Approves Treatment for Rare Blood Disease

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

Biologics: Innovations, Challenges, and the Road Ahead

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

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

Dentitox Pro – Text Presentation

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

U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

Metabolism of 2023 FDA Approved Small Molecules – PART 1

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer

The science of ageing and restoring healthspan

Aurinia Pharmaceuticals to Present at Two Upcoming Virtual Healthcare Conferences

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

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

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

AbbVie to Present Data From Its Migraine Portfolio at the.

FIRST-LINE TREATMENT FOR ALK-POSITIVE METASTATIC LUNG CANCER

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

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone.

Amgen Presents New Data From Thoracic Oncology Portfolio At WCLC21

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

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

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

Janssen Presents Results from Phase 3 ACIS

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

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