United States Food and Drug Administration
Merck’s Enflonsia FDA Approval Spurs Sanofi to Accelerate Beyfortus Supply Ahead of 2025-26 RSV Season
RSV; Infant immunization; Merck; Sanofi; Beyfortus; Enflonsia; FDA approval; supply chain; healthcare; AstraZeneca
Otsuka’s Phase 3 IgAN Win with Sibeprenlimab Shakes Vera’s Stock
Otsuka; sibeprenlimab; IgA nephropathy; phase 3 trial; proteinuria reduction; Vera Therapeutics; stock drop; kidney disease; UPCR; FDA Priority Review
Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China
FDA; biotech; regulation; modernization; China; cell and gene therapy; CEO roundtable; competitiveness; innovation
RadNet Acquires See-Mode to Expand AI Ultrasound for Breast and Thyroid Cancer Diagnostics
RadNet; See-Mode Technologies; AI ultrasound; breast cancer; thyroid cancer; DeepHealth; diagnostic imaging; FDA approval; workflow efficiency; acquisition
Sarepta’s rAAVrh74 Viral Vector Receives FDA Platform Technology Designation for Gene Therapy
Sarepta Therapeutics; FDA; platform technology designation; rAAVrh74 viral vector; gene therapy; SRP-9003; limb-girdle muscular dystrophy; rare diseases
FDA Approves Moderna’s Next-Generation Covid Vaccine With Limited Use for Most Healthy People
Moderna; FDA approval; mNexspike; next-generation Covid vaccine; vaccine restrictions; Covid-19; Spikevax; elderly; high-risk medical conditions; Omicron JN.1 variant
J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear
Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)
Moderna’s Next-Generation COVID Shot Gets FDA Backing With Usage Limitations
Moderna; COVID-19 vaccine; FDA approval; mNEXSPIKE; mRNA-1283; next-generation vaccine; respiratory virus season; age restriction; underlying conditions; vaccine efficacy
Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline
Sanofi; Regeneron; COPD; itepekimab; IL-33; Phase 3 trials; AERIFY-1; AERIFY-2; FDA approval; clinical trial results
FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval
FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay