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Drug Approval Process

Merck Ends Revolution Medicines Takeover Talks After Valuation Standoff

Interest centered on Revolution’s late-stage pan‑RAS drug daraxonrasib, a key driver of the biotech’s standalone prospects.

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation, Sets April 30 PDUFA Date

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

FDA Accepts Sonrotoclax NDA, Grants Priority Review for Relapsed Mantle Cell Lymphoma

Nuvalent Reports 31% ORR in Pretreated, 86% in Untreated ALK+ NSCLC With Neladalkib

FDA Removes Broad Boxed Warnings From Many Menopause Hormone Therapies

FDA Rejects Biohaven’s Vyglxia for Spinocerebellar Ataxia

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

FDA Opens Door to Reconsider Capricor’s Duchenne Cell Therapy Based on HOPE-3 Data

FDA Suspends Valneva’s Ixchiq Chikungunya Vaccine Over Safety Reports

FDA Approves Ionis’ Dawnzera to Prevent Hereditary Angioedema Attacks

FDA Lifts Hold on Elevidys Shipments to Ambulatory Duchenne Patients

Regulators Halt Elevidys Gene Therapy Worldwide After Safety Failures

FDA Flags Possible License Revocation for Sarepta’s Elevidys

Sarepta Temporarily Halts Elevidys Shipments Under FDA Request

Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market

Sarepta Shares Plummet on FDA Review of Elevidys Following Third Patient Death

Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure