The day in pharma, read in minutes.
NewsAbbVie Reports Higher Endoscopic Remission in Crohn’s Trial
AbbVie's Phase 2a dual-targeting Crohn's trial shows higher remission rates, raising bioprocessing and analytical complexity questions for manufacturing teams.
Dr. Reddy's Gains DCGI Approval for Zytorvi in Esophageal Cancer
Achieve Reports 52-Week Cytisinicline Results at CHEST 2026
AstraZeneca-Oracle AI Partnership Targets Faster Clinical Trials
Sutro Biopharma Doses First Patient in Phase 1 STRO-006 Trial
Latest news
11 storiesUnicycive Gains FDA Acceptance for OLC NDA Resubmission
FDA accepts Unicycive's OLC NDA resubmission as Class II with a March 25, 2027 PDUFA date, following a CMC vendor switch after two CRLs.
Abbott Plans to Spin Off Its $8.5B Nutrition Business by 2027
Abbott plans to spin off its $8.5B Nutrition unit by end-2027, separating 14 manufacturing sites into a standalone public company.
Olympus Faces FDA Import Alert Over Quality System Violations
FDA issues Import Alert 89-04 against Olympus Medical Systems, blocking U.S. entry of six endoscopic device categories over unresolved Quality System violations.
Genentech Secures Regular FDA Approval for Pralsetinib
FDA converts pralsetinib to regular approval for RET fusion-positive NSCLC, setting a confirmatory trial benchmark for oncology regulatory teams.
Telix Wins FDA Approval for Pixclara and Announces ITM Merger
Telix gains FDA approval for Pixclara and announces ITM merger, reshaping radiopharmaceutical manufacturing scale and isotope supply chain resilience.
FDA Finalizes Guidance on Prescription Drug-Related Software
FDA finalizes guidance applying drug labeling authorities to software outputs disseminated by prescription drug and combination product sponsors.
FDA Launches Plan to Expand Nonprescription Drug Access
FDA's structured Rx-to-OTC stakeholder engagement plan advances with a 2026 pilot program and forthcoming draft guidance on switch criteria.
GSK Wins FDA Approval for Hibsago in Chronic Hepatitis B
GSK's Hibsago becomes the first FDA-approved ASO for chronic HBV, with a companion diagnostic requirement and boxed warning for hepatic and hematologic risks.
Zydus Wins FDA Approval for First Generic Climara Pro Patch
Zydus Pharmaceuticals gains FDA approval for the first generic of Climara Pro, a once-weekly combination estradiol-levonorgestrel transdermal patch.
Baxter Receives FDA Warning Letter Over CGMP Violations
FDA cites Baxter's Round Lake facility for cephalosporin cross-contamination and inadequate environmental monitoring under 21 CFR 211.42(c).
Rohto Receives FDA Warning Letter for Vietnam CGMP Failures
FDA issued Rohto Pharmaceutical a warning letter citing CGMP failures at its Vietnam facility and unapproved drug claims across seven OTC eye drop lines.
Worth your time this week
Hepion Gains FDA Guidance for GV104 Gambling Disorder Trial
FDA Posts September 2026 Pediatric Advisory Committee Materials
Dogwood Therapeutics Secures $5M for Halneuron Phase 3 Prep
