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NewsAbbVie Achieves Phase 3 HiSCR75 Primary Endpoint for Lutikizumab
AbbVie's lutikizumab met the HiSCR75 primary endpoint and 8 secondary endpoints in Phase 3 INTREPID, signalling a likely BLA submission path.
Insmed Wins Japan Approval for Brinsupri in Bronchiectasis
FDA Grants Ultomiris Accelerated Approval for IgA Nephropathy
Novartis Wins EU Approval for Cosentyx in Polymyalgia Rheumatica
AbbVie Reports Higher Endoscopic Remission in Crohn’s Trial
Latest news
11 storiesDr. Reddy's Gains DCGI Approval for Zytorvi in Esophageal Cancer
Dr. Reddy's secures DCGI approval for Zytorvi in advanced esophageal cancer, expanding beyond its original NPC indication.
Achieve Reports 52-Week Cytisinicline Results at CHEST 2026
Achieve Life Sciences' ORCA-OL trial shows 39% quit rate at 52 weeks in placebo-prior patients, raising CMC and NDA readiness questions.
AstraZeneca-Oracle AI Partnership Targets Faster Clinical Trials
AstraZeneca and Oracle partner on AI to cut clinical trial delays, with downstream implications for CMC timelines and regulatory submissions.
Sutro Biopharma Doses First Patient in Phase 1 STRO-006 Trial
Sutro Biopharma doses first patient in Phase 1 STRO-006 trial, its DAR8 ITGB6-targeting ADC built on site-specific cell-free conjugation.
Unicycive 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.
Worth your time this week
GSK Wins FDA Approval for Hibsago in Chronic Hepatitis B
Zydus Wins FDA Approval for First Generic Climara Pro Patch
Baxter Receives FDA Warning Letter Over CGMP Violations
