FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA
Approval of YARTEMLEA was based on results from a single-arm, open-label study in adults with TA-TMA (the TA-TMA…
FDA voucher program has led to political interference in drug reviews, staffers say
WASHINGTON — A new program intended to fast-track drug reviews at the Food and Drug Administration is quickly…
Female libido pill gets expanded approval for menopause by FDA
U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now…
Will FDA Approval of an In‑House Teriparatide Pen Reshape Amphastar Pharmaceuticals’ (AMPH) Narrative?
In December 2025, Amphastar Pharmaceuticals announced that the FDA approved its abbreviated new drug application for a teriparatide…
Amphastar Announces FDA Approval for Teriparatide Injection
RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the…
Childhood Vaccine Upheaval Won’t Stop With Changes In Hep B Guidance
Dr. Retsef Levi speaks during a meeting of the Advisory Committee in Immunization Practices. ACIP is changing its…
Regulatory reform can unlock access to biosimilars
Every day, I think about the patients waiting for medicines that could change, or even save, their lives.…
Otsuka’s kidney therapy gets accelerated FDA approval
Voyxact gets accelerated approval, offering investors a new entrant in the high-value kidney disease market. The Food and…
FDA offers staff “agentic AI” to support pre-market reviews, other tasks
Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics.…
MannKind Announces U.S. FDA Accepts for Review its
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10…
Walgreens recalls nasal spray over possible contamination
(CNN) – Walgreens is recalling more than 41,000 bottles of nasal spray because they may be contaminated with…
Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg
If approved, investigational semaglutide 7.2 mg injection would offer the optionality of a higher dose for greater weight…