United States Food and Drug Administration
Insmed’s TPIP PAH Therapy Advances to Phase III Following Positive Phase 2b Results
Insmed; TPIP; treprostinil palmitil inhalation powder; pulmonary arterial hypertension; PAH; Phase 2b trial; Phase III trial; clinical trial results; FDA engagement
Axsome Plots New Fibromyalgia Trial After FDA Refuses Review of Former Pfizer Candidate
Axsome Therapeutics; esreboxetine; fibromyalgia; FDA; refusal to file; clinical trial; Pfizer; AXS-14; trial design; pain medicine
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