United States Food and Drug Administration

FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals

15 hours ago talkbio0Tagged Drug Approval, early-phase trials, real-world data, real-world evidence, Real-world Evidence, RWE, Transplant Registry Unified Management Program, Trump, United States Food and Drug Administration

FDA; real-world data; real-world evidence; RWE; early-phase trials; drug approval; Marty Makary; Trump

J&J’s Tecvayli and Darzalex Combo Wins FDA’s Proactive National Priority Voucher for Relapsed/Refractory Multiple Myeloma

19 hours ago talkbio0Tagged Asymmetric Septal Hypertrophy, CNPV, Darzalex, J&J, Multiple Myeloma, National Priority Voucher, TECVAYLI, United States Food and Drug Administration

J&J; FDA; National Priority Voucher; Tecvayli; Darzalex; Multiple Myeloma; CNPV; ASH 2025

FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer

23 hours ago talkbio0Tagged Approved, Carcinoma breast stage IV, Enhertu, first-line, HER2-positive, Perjeta, United States Food and Drug Administration

Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line

Kyverna to seek FDA engagement after positive autoimmune CAR-T data in stiff person syndrome

23 hours ago talkbio0Tagged Autoimmune Diseases, CAR-T, Cell Therapy, KYV-101, Kyverna, Regulatory Path, SPS, Stiff-Person Syndrome, United States Food and Drug Administration

Kyverna; KYV-101; CAR-T; autoimmune disease; stiff person syndrome; SPS; FDA; regulatory path; cell therapy

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

2 days ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

FDA approves new gonorrhea antibiotics from GSK and Innoviva

5 days ago talkbio0Tagged Antibiotic Resistance, Microbial, Approved, Blujepa, first-in-class antibiotic, gepotidacin, Gonorrhea, Gonorrhea genitourinary NOS, Innoviva, Nuzolvence, Oral treatment, SmithKline Beecham, Uncomplicated, United States Food and Drug Administration, zoliflodacin

gonorrhea; antibiotic resistance; GSK; Blujepa; gepotidacin; Innoviva; Nuzolvence; zoliflodacin; FDA approval; uncomplicated urogenital gonorrhea; first-in-class antibiotic; oral treatment

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

5 days ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

The Endpoints 100: Biotech CEOs are feeling more upbeat about the road ahead

5 days ago talkbio0Tagged Attitude, biopharma executives, CEOs, dealmaking, E100 survey, Endpoints, Industry, IPO, Market, Recovery - action, reorganization, Sentiment, Trump administration, United States Food and Drug Administration, Window (physical object)

Endpoints 100; E100 survey; biotech CEOs; biopharma executives; industry sentiment; market recovery; dealmaking; IPO window; Trump administration; FDA reorganization; tariffs; 2025 outlook

CDC highlights strong effectiveness of 2024–2025 COVID-19 shots in kids while FDA reviews reports of alleged post-vaccination deaths

5 days ago talkbio0Tagged alleged deaths, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Effectiveness, Emergency department patient visit, Pediatrics, safety review, United States Food and Drug Administration, urgent care visits, Vaccines, VAERS

CDC; FDA; COVID-19 vaccine; children; pediatrics; vaccine effectiveness; emergency department visits; urgent care visits; safety review; alleged deaths; VAERS

FDA Approves GSK’s Gepotidacin (Blujepa) for Uncomplicated Urogenital Gonorrhea

5 days ago talkbio0Tagged Antibiotics, Approved, Blujepa, gepotidacin, Gonorrhea, SmithKline Beecham, United States Food and Drug Administration

GSK; gepotidacin; Blujepa; FDA approval; gonorrhea; antibiotic