Human-caused Phenomenon or Process
FDA Advisory Committee Votes Against Ocaliva for Primary Biliary Cholangitis Due to Safety Concerns
Ocaliva, FDA, Primary Biliary Cholangitis, Liver Disease, Safety Concerns, Advisory Committee Vote
GSK Advances mRNA Flu Vaccine to Late-Stage Clinical Development Following Positive Phase II Results
GSK, mRNA flu vaccine, phase II results, late-stage clinical development, influenza A and B strains, vaccine efficacy, safety profile.
Roche’s Obesity Pill Candidate Faces Safety Concerns Amid Promising Efficacy Results
Roche, Obesity Pill, Safety Concerns, Efficacy Data, CT-996, Side Effects, Nausea, Vomiting, Gastrointestinal Issues
EU High Court Rules in Favor of Illumina in Grail Acquisition Appeal
Illumina, Grail, European Court of Justice, Acquisition, Antitrust Litigation, Liquid Biopsy
Recursion’s Phase 2 Trial for Cerebral Cavernous Malformation Shows Limited Efficacy Despite Meeting Safety Goals
Recursion Pharmaceuticals, Phase 2 trial, cerebral cavernous malformation (CCM), REC-994, safety and tolerability, efficacy data, FDA meeting
Autoimmune CAR-Ts Under Scrutiny Following Cabaletta’s Safety Concerns in Lupus Treatment
Autoimmune CAR-T, Cabaletta, Lupus, Safety Concerns, Clinical Trials
Nuvation Bio Halts Development of BET Inhibitor NUV-868 Following Interim Phase 1 Data Review
Nuvation Bio, BET inhibitor, NUV-868, Phase 1 data, oncology drug, safety and efficacy, clinical trials
US Government Appeals Jury Decision in High-Stakes HIV PrEP Patent Battle Against Gilead
HIV, PrEP, Patent Battle, Gilead, Truvada, Descovy, US Government, Patent Litigation
FDA Halts BioNTech-MediLink ADC Trial Due to ‘Significant Risk of Illness or Injuries’
FDA, BioNTech, MediLink, ADC, Clinical Trial, Safety Concerns, Cancer Treatment
PTC Therapeutics Reports Positive Phase II Huntington’s Disease Data, FDA Lifts Partial Clinical Hold
PTC Therapeutics, Huntington’s disease, Phase II data, FDA, partial clinical hold, PTC518, mutant huntingtin protein, clinical trends, safety, tolerability.