United States Food and Drug Administration
FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return
GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma
FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin
FDA; user fees; PDUFA VIII; regulatory policy; drug approval; fee structure; negotiations
Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings
Takeda; Oveporexton; narcolepsy; Phase III trials; orexin agonist; FDA filing; Narcolepsy Type 1; clinical trial results
FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues
FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay
WHO to Develop Guidelines for Gilead’s Twice-Yearly HIV PrEP Injection (Lenacapavir)
WHO; Gilead; Lenacapavir; twice-yearly injection; PrEP; HIV prevention; guidelines; FDA approval
FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy
FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter
Moderna’s COVID Vaccine Wins FDA Approval for At-Risk Young Children
Moderna; FDA approval; COVID vaccine; children; at-risk; Spikevax; underlying conditions; full approval
FDA Commissioner Makary Proposes Fast-Track Drug Review Vouchers Tied to Lower US Prices, Without Detailing Criteria
FDA; Makary; national priority review vouchers; drug pricing; fast-track approval; price parity; pilot program
FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk
FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6
Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity
Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference