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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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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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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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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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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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.

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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.

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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.

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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.

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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.

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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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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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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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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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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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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.

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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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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 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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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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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

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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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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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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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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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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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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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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.

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The Pharma Data

SEPTEMBER 28, 2021

The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to 6 weeks aged and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne dystrophy (DMD).

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Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. His mother had a presentation of the disease that suggested her immune system was already on the job.

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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. .

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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.

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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.

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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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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.

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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),

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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: .

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