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 ...
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 ...
(RTTNews) - May has just begun, and it's time to turn our attention to the FDA decisions on deck for the coming weeks. So far this year, the U.S. regulatory agency has approved only nine novel drugs - ...
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 ...
WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...
FDA approval for Lytenava might come next week, I see Outlook Therapeutics at a pivotal inflection point, offering a rare asymmetric risk/reward setup. Lytenava’s European approval, decade-long ...
(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 ...
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