MarketPulse

FDA warning

6 articles
BenzingaBenzinga··Vandana Singh

Amgen's Japanese Partner Issues Caution Alert on Tavneos Amid FDA Safety Concerns

Kissei Pharmaceutical urges caution on Tavneos use following FDA safety warnings and data integrity concerns, proposing withdrawal of the Amgen drug's approval.
AMGNclinical trialdrug safety
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Gemini Space Station Hit With Class Action Lawsuit Over Alleged Crypto Platform Misstatements

Kahn Swick & Foti represents investors in class action against Gemini Space Station for alleged crypto platform misstatements. Lead plaintiff applications due May 18, 2026.
IBRXGEMISMCIsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Kahn Swick & Foti, Llc

Soleno Therapeutics Faces Securities Fraud Lawsuit Over Undisclosed DCCR Safety Risks

Soleno Therapeutics faces securities fraud lawsuit alleging undisclosed DCCR safety risks. Investors must file by May 5, 2026.
IBRXSMCISLNOsecurities fraudclass action lawsuit
BenzingaBenzinga··Vandana Singh

ImmunityBio Surges on Strong Q1 Revenue, But FDA Warning Clouds Outlook

ImmunityBio stock rallied 7% after reporting $44.2M in Q1 product revenue, up 168% YoY, despite FDA warning over Anktiva marketing claims.
IBRXAnktivaImmunityBio
BenzingaBenzinga··Vandana Singh

FDA Warns ImmunityBio Over Anktiva Cancer Claims Despite Strong 750% Sales Surge

FDA flagged ImmunityBio for unsupported Anktiva cancer cure claims. Company implemented corrective measures while reporting 750% unit volume growth and $38.29M quarterly revenue.
IBRXsales growthregulatory compliance
BenzingaBenzinga··Vandana Singh

Amgen's Tavneos Faces FDA Warning Over Fatal Liver Injuries

FDA warns of 76 drug-induced liver injury cases linked to Amgen's Tavneos, including 8 deaths and severe bile duct syndrome, raising significant safety and commercial concerns.
AMGNFDA warningliver injury