Nasdaq

Biotech Stocks Facing FDA Decision In November 2025

(RTTNews) - November, a month best known for Thanksgiving and harvest festivals, is also an important month for raising awareness about various health issues. Some of the key health observances in ...
KETV Omaha

Omaha mom expects new FDA decision on son's 'lifesaving' drug soon

OMAHA AND COUNCIL BLUFFS ANY DAY NOW IN OMAHA, WOMAN EXPECTS A DECISION FROM THE FDA. SHE SAYS IT WILL DECIDE WHETHER HER SON LIVES OR DIES. LAST MONTH, KETV NEWSWATCH SEVEN’S ERIN HAGERTY BROUGHT YOU ...
Forbes

A Looming FDA Decision, Approval Odds, Investor Takeaways

Late-stage biopharma Scholar Rock (SRRK) is approaching a pivotal catalyst: the FDA decision on apitegromab, its investigational muscle-targeted therapy for spinal muscular atrophy (SMA). A verdict is ...
Seeking Alpha

UroGen Pharma: ODAC Decision Puts Drug Approval In Limbo, But It's Not Over, Either

UroGen Pharma Ltd.'s investment thesis hinges on FDA approval of UGN-102, a minimally invasive bladder cancer treatment with a June 13 decision date. ODAC narrowly voted against approval, citing ...
Seeking Alpha

Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review ...
Nasdaq

Biotech Stocks Facing FDA Decision In August 2025

(RTTNews) - As July draws to a close, it's time to take a look at what's in store in the health and wellness space over the upcoming weeks. August, the last month of summer, includes several health ...