ENTITY – Talk Bio

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

SABCS 2025 Highlights: Celcuity’s Phase 3 VIKTORIA-1 Updates and Relay PI3K Inhibitor News

12 hours ago talkbio0Tagged Celcuity, gedatolisib, Malignant neoplasm of breast, Phase 3, PI3 K inhibitors, PIK3CA gene, Relay Device, SABCS25, VIKTORIA-1, wild-type

SABCS25; Celcuity; VIKTORIA-1; gedatolisib; PIK3CA wild-type; Phase 3; breast cancer; Relay; PI3K inhibitors

Innovent’s Mazdutide Shows Promising Obesity Data in Adolescents; No Everest PCSK9 News

16 hours ago talkbio0Tagged Adolescent (age group), China, Innovent, mazdutide, Obesity, Phase 1b, Weight Loss

Innovent; mazdutide; obesity; adolescents; Phase 1b; weight loss; China

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

Pfizer, Geron Downsize to Streamline Costs

17 hours ago talkbio0Tagged commercial strategy, cost-cutting, Geron, Pfizer, Rytelo, Staff, Switzerland

Pfizer layoffs Switzerland; Geron layoffs one-third staff; cost-cutting; restructuring plan; Rytelo commercial strategy; Pfizer cost realignment; biopharma layoffs 2025