Pharmacologic Substance

FDA approves new gonorrhea antibiotics from GSK and Innoviva

2 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

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

2 days 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

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

3 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

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

3 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

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

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

Image Analysis Group Partners with Better Medicine for AI-Driven Oncology Clinical Trial Imaging

3 days ago talkbio0Tagged AI oncology imaging, central reads, Clinical Trials, DYNAMIKA, Image Analysis Group

Image Analysis Group; Better Medicine; AI oncology imaging; clinical trials; DYNAMIKA; central reads

Pfizer’s Tukysa Shows Strong PFS Benefit in First-Line HER2+ Breast Cancer Maintenance at SABCS 2025, Sparking Debate with Enhertu

3 days ago talkbio0Tagged Enhertu, first-line maintenance, HER2-positive carcinoma of breast, HER2CLIMB-05, Pfizer, Progression-Free Survival, SABCS, Tukysa

Tukysa; Pfizer; HER2-positive breast cancer; SABCS 2025; HER2CLIMB-05; progression-free survival; Enhertu; first-line maintenance

Lilly’s triple agonist retatrutide posts strongest weight-loss data to date, with unusual sensory skin side effect reported

3 days ago talkbio0Tagged Abnormal, aspects of adverse effects, Dysesthesia, Eli, Eli Lilly, Gastric Inhibitory Polypeptide, glucagon, Glucagon-Like Peptide 1, Obesity, Phase III, retatrutide, safety signal, sense of, Therapeutic tactile stimulation, triple agonist, triple hormone receptor agonist, TRIUMPH-4, Weight Loss

Eli Lilly; retatrutide; triple agonist; triple hormone receptor agonist; GLP-1; GIP; glucagon; obesity; weight loss; TRIUMPH-4; Phase III; dysesthesia; abnormal sense of touch; safety signal; side effects

Roche breast cancer pill cuts post-surgery recurrence risk by 30% in major trial

4 days ago talkbio0Tagged Adjuvant Therapy, Disease-Free Survival, ER-positive, giredestrant, HER2-negative, hormone receptor-positive, Hormone Therapy, Malignant neoplasm of breast, Oral SERD, phase III lidERA trial, Recurrence Risk, Roche (company), San Antonio Breast Cancer Symposium

Roche; giredestrant; breast cancer; hormone receptor-positive; ER-positive; HER2-negative; oral SERD; endocrine therapy; adjuvant therapy; recurrence risk; phase III lidERA trial; disease-free survival; San Antonio Breast Cancer Symposium

Updated Efficacy Data of Ivonescimab Plus Chemotherapy as First-Line Treatment for TNBC at ESMO IO 2025

4 days ago talkbio0Tagged AK112 - 308, Breakthrough Therapy Designation, Combined, Complex partial seizures, disease control rate, ESMO IO, First line treatment, Frequency of Responses, HARMONi-BC1, Ivonescimab, PD-1/VEGF bispecific antibody, PD-L1, Pharmacotherapy, Phase 2 Clinical Trials, Progression-Free Survival, safety profile, Subgroup A Nepoviruses, TNBC, Triple Negative Breast Neoplasms, Yidafan

ivonescimab; Yidafan; PD-1/VEGF bispecific antibody; triple-negative breast cancer; TNBC; first-line treatment; ESMO IO 2025; Phase II trial; chemotherapy combination; objective response rate; progression-free survival; disease control rate; PD-L1 CPS subgroups; safety profile; Breakthrough Therapy Designation; HARMONi-BC1; AK112-308