Nasdaq3d
Teva Pharmaceuticals and Alvotech Announce FDA Approval of SELARSDI™ Biosimilar for Multiple Indications
The FDA's provisional determination of interchangeability ... Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI (ustekinumab-aekn ...
Invivyd shares drop as FDA declines company's COVID-19 treatment EUA expansion
Monday said that its request to expand the existing emergency use authorization of PEMGARDA (pemivibart) to include treatment of mild-to-moderate COVID-19 for immunocompromised persons who have no ...
Nasdaq3d
NKGen Biotech Doses First FTD Patient With Troculeucel Under FDA Compassionate Use
(RTTNews) - NKGen Biotech (NKGN), Friday revealed the administration of the first dose of its autologous NK cell therapy, troculeucel, to a frontotemporal dementia or FTD patient under an FDA ...
Nasdaq4d
BridgeBio Pharma Reports Significant Launch Progress for Attruby™ Following FDA Approval and EU Marketing Authorization
1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval, indicating strong initial market uptake. Attruby™ is the first and only near ...
Nasdaq10d
Moleculin Gets FDA Guidance To Accelerate MIRACLE Trial For R/R AML
Annamycin holds Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory ... trading at $1.7 or 304.7620% higher on the Nasdaq Capital Market. The views and opinions ...
Nasdaq7d
FDA Approves Merilog Rapid-Acting Insulin Biosimilar For Diabetes
The FDA noted that Merilog is the third insulin ... 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 ...
Nasdaq6d
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 ...
Nasdaq7d
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 ...
Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ...
SpringWorks shares rise on FDA nod for GOMEKLI
Shares of SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) climbed 2.7%, building on a previous gain of 2%, following the FDA ...
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 ...