Posts

Recent News About Tris Pharma's Narcolepsy Drug and Agenus' Phase 3 CRC Trial Abandonment

on

Production problems hamper Lantheus bid for FDA approval of LNTH-2501 radiopharma diagnostic kit

on

Atara and Pierre Fabre Secure FDA Type A Meeting for Ebvallo After Second CRL, Amid Leadership Shifts

on

FDA's Shock Rejection of Ebvallo Cell Therapy: Reconsideration Efforts and uniQure Concerns

on

Unnamed Pharma Files Citizen Petition Urging FDA to Reform CRL Disclosure Practices

on

Incyte Receives FDA CRL for Zynyz NSCLC Expansion Due to Issues at Novo Nordisk's Catalent Indiana Facility, Becoming Third Affected Company

on

AstraZeneca Receives FDA Complete Response Letter for Subcutaneous Saphnelo in Lupus

on

FDA Issues Complete Response Letter to Aquestive's Anaphylm Over Packaging and Human Factors Issues

on

KOL Bulletin: ONS-5010's Bigger Opportunity May Lie Outside the US After FDA's Third CRL, KOL Says

on

FDA Rejects Biohaven's Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure

on

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

on