FDA declares Wegovy and Ozempic shortage over, Novo Nordisk confirms
Novo Nordisk (NVO) announced that the U.S. Food and Drug Administration has determined the shortage of Wegovy and Ozempic is resolved. “The ...
Nasdaq4d
Spectral AI Strengthens Financial Position Ahead of FDA Submission
DALLAS, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI ... Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI ...
Aspire Biopharma Holdings, Inc., Announces Public Listing on Nasdaq
The closing of the business combination with PowerUp Acquisition Corp. creates Nasdaq-listed biopharmaceutical company dedicated to developing breakthrough innovations in FDA approved drugs, ...
Travere Therapeutics, Inc. (NASDAQ:TVTX) Q4 2024 Earnings Call Transcript
Q4 2024 Earnings Call Transcript February 21, 2025 Operator: Good afternoon, and welcome to the Travere Therapeutics Fourth ...
Nasdaq3d
Harmony Biosciences Receives FDA Refusal To File Letter For Pitolisant In Idiopathic Hypersomnia
(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) Wednesday said that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the ...
MassDevice1d
iRhythm stock rises on Q4 results, on-target FDA remediation efforts
Rhythm (Nasdaq: IRTC) shares got a boost today on fourth-quarter results that came in ahead of the consensus forecast on Wall ...
Teva and Alvotech gets FDA review acceptance for its proposed biosimilar to Eylea
Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals (NYSE:TEVA) said on Tuesday that the U.S. FDA has accepted for review a ...
Nasdaq5d
Innate Pharma : FDA Grants Breakthrough Therapy Designation To Lacutamab For R/R Sezary Syndrome
The FDA's Breakthrough Therapy Designation aims ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...