Finding
Akeso, Summit’s PD-1/VEGF bispecific records another pivotal study win in NSCLC
Ivonescimab, Non-Small Cell Lung Carcinoma, Akeso, PD-1/VEGF, Keytruda, summit, Pharmacotherapy, Combined, Safety
Bristol Myers’ schizophrenia drug Cobenfy stumbles as adjunctive treatment, denting blockbuster plan
Cobenfy, Schizophrenia, Antipsychotic Agents, Adjunctive Orthodontic Procedure, Myers, Statistical Significance, Improvement, Single Agent Therapy
HR25: LifeSignals launches cardiac monitoring patch to compete with iRhythm, Philips
Preventive monitoring, Plaque (lesion), Philips, Heart, iRhythm, LifeSignals, Medical Devices
RFK Jr.’s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters
United States Food and Drug Administration, Does speak, Staff, negotiators, HHS, Mediation, user fee, Fees, Drug Industry
UK approval brings GSK’s Blenrep back from the brink
UK, Approved, Multiple Myeloma, DREAMM-8, dexamethasone, Blenrep, Antibody-Drug Conjugates, Risk, Cessation of life
Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss
orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables
Leaked HHS budget signals $40B in cuts, assumes ACA subsidies expire
Budgets, HHS, Patient Protection and Affordable Care Act, Subsidies, Agencies, Leaked, Administration occupational activities, proposal – intent, assumes, Programs – Publication Format
FDA clears its first prescription migraine app, from Click Therapeutics
United States Food and Drug Administration, CT-132, Migraine Disorders, Click Therapeutics, click, first
HHS Terminates Funding for GeoVax’s Next-Generation COVID-19 Vaccine: Impacts and Developments
GeoVax, HHS, BARDA, Project NextGen, COVID-19 vaccine, GEO-CM04S1, clinical trials, funding termination, immunocompromised, vaccine development, pandemic preparedness
Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg
United States Food and Drug Administration, public health medicine (field), Changing, Vaccines, Leadership, Policy, drug safety, Previous, KAT5 wt Allele, Icebergs, Disease Outbreaks, Alarm device, Visible