FDA Accepts Biogen's New Drug Application and Grants Priority ...

FDA's accelerated approval process: What your audience needs to ...

But the FDA has accepted Sarepta's delays in completing this work. The key trial of the drug is now expected to finish around 2026, according to ...

Biogen Soars As FDA Accepts Alzheimer's Drug For Review In 'Next ...

Biogen Inc's (NASDAQ: BIIB) investigational Alzheimer's drug aducanumab — a drug for which the company halted studies at one point last year ...

FDA Updates: Brilinta's Priority Review in Stroke; Biogen's ...

Biogen announced it completed submission of a Biologics License Application (BLA) for aducanumab, a monoclonal antibody to treat Alzheimer's ...

BioPharma Dive: Biotech and Pharma Industry News

Top stories · Q&A // ALS drug development. How a Biogen drug set the stage for a new biotech targeting ALS · Trump names RFK Jr. as his pick to lead HHS · Merck, ...

Lecanemab - Wikipedia

Lecanemab, sold under the brand name Leqembi, is a monoclonal antibody medication used for the treatment of Alzheimer's disease.

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Latest News in the Pharma Industry: Policy & Regulation - CPHI Online

The US Food and Drug Administration (FDA) accepts for review Pfizer and Eli Lilly's Biologics License Application (BLA) for tanezumab — a non-opioid treatment ...

In Brief This Week: MD Anderson, Genascence, Seattle Children's ...

In addition, the coalition will seek to enroll 3,300 new participants with opioid use disorder. Collaborators include Weill Cornell Medicine, ...

Ionis reports third quarter 2024 financial results

NDA for patients with FCS under FDA Priority Review with a PDUFA date of December 19, 2024 · Marketing authorization application (MAA) under ...

Medical Devices Applying for Outpatient Medicare Supplemental ...

In 2020, CMS introduced an alternative pathway to allow US Food and Drug Administration (FDA)-designated breakthrough devices to qualify for ...

DEPARTMENT OF HEALTH AND HUMAN SERVICES - Project 2025

15 Additionally, FDA and NIH should promote efficacy trials of new applications for generic drugs, which might include NIH fund- ing such trials or ...

Pharmaceuticals - CNBC

FDA proposes ending use of decongestant found in many cold, allergy medicines ... Merck tops earnings estimates on strong demand for Keytruda, new drugs.

Voyager Therapeutics, Inc. (VYGR) Q3 2024 Earnings Call Transcript

Call Start: 16:30 January 1, 0000 5:07 PM ETVoyager Therapeutics, Inc.