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

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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.

The Senate has narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration, filling a position that had been open for more than a year

The shares of medical technology stock Senseonics Holdings (SENS) dipped marginally in price yesterday, despite the company receiving FDA approval for its Eversense E3 glucose monitoring system. So, with unsustainable valuations and a bleak earnings outlook, will SENS'stock be able to regain forward momentum soon? Read more to learn our…