The Latest Breaking News from FDA

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) marketing application for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol) 

Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Amylyx's ALS Treatment Regulatory Application To Be Reviewed By FDA Panel In Late March

The drug industry, patient advocates and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism and discrimination against the disabled — and hinted at a lawsuit — over the…

Outset Medical Inc (NASDAQ:OM) recorded Q4 FY21 net revenue of $28.2 million, a 63.2%, beating the consensus of $26.42 million. Product revenue for the fourth quarter of 2021 was $23.7 million, +79.5%. The Company achieved a gross margin of 11.8%, compared to 2.4% in the fourth quarter of 2020 Select Development:  The…

By David Bautz, PhD OTC:ATBPF | TSX:ATE.TO READ THE FULL ATE.TO RESEARCH REPORT

By a narrow vote of 50-46, the Senate has confirmed Robert Califf to run the FDA.

The 

Avenue Therapeutics Inc (NASDAQ: ATXI) announced the outcome of the FDA meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.

WASHINGTON — Advocates on both sides of a debate over dramatically restricting Medicare’s coverage of an expensive and controversial Alzheimer’s treatment are waging competing campaigns to influence a final decision in April.

WASHINGTON — The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

The agency has been without a permanent leader for more than a year.