United States Food and Drug Administration

FDA approves new gonorrhea antibiotics from GSK and Innoviva

12 hours 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

16 hours 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

16 hours 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

17 hours 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

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

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

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

2 days ago talkbio0Tagged 2025, Accountability, AI-enabled, clinical oversight, digital health regulation, digital mental health devices, draft guidance, EU, EU AI Act health, Generative AI, Health care facility, Medical Devices, Regulation, Software as a Medical Device, United States Food and Drug Administration

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

FDA reviews safety of approved RSV antibodies for infants

3 days ago talkbio0Tagged AstraZeneca, Beyfortus, Infant, Merck, nirsevimab, palivizumab, Respiratory syncytial virus, RSV antibodies, safety review, sanofi, United States Food and Drug Administration

FDA; RSV; nirsevimab; Beyfortus; palivizumab; RSV antibodies; infant safety review; Sanofi; AstraZeneca; Merck; respiratory syncytial virus

FDA Broadens COVID-19 Vaccine Safety Probe to Adults Under New Health Leadership

3 days ago talkbio0Tagged Adult, COVID19 (disease), Moderna, Myocarditis, Pfizer, public trust, safety review, United States Food and Drug Administration, vaccine deaths, Vaccines

FDA; COVID-19 vaccines; safety review; adults; Robert F. Kennedy Jr.; vaccine deaths; public trust; Pfizer; Moderna; myocarditis

Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

3 days ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

PathAI’s AIM-MASH AI Assist Receives Historic FDA Qualification for MASH Clinical Trials

3 days ago talkbio0Tagged AI Assist, AIM-MASH, biomarker qualification, Biopsy of liver (procedure), Clinical Trials, Drug Development Tool, EMA qualification, Histology, MASH, MASLD, metabolic dysfunction-associated steatohepatitis, Nonalcoholic Steatohepatitis, PathAI, Pathology, Qualification, United States Food and Drug Administration

PathAI; AIM-MASH; AI Assist; FDA qualification; Drug Development Tool; biomarker qualification; MASH; MASLD; NASH; metabolic dysfunction-associated steatohepatitis; AI pathology; clinical trials; EMA qualification; liver biopsy; histology