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NewsIDEAYA Biosciences Achieves 17.4-Month Median OS with IDE849 ADC in Relapsed SCLC
IDEAYA's IDE849 ADC posts 17.4-month median OS in 2L SCLC at ESMO 2026, with two Phase 3 trials now in targeting range.
FDA Issues Twelve Biologics Guidance Documents Covering Container Closure, Blood Manufacturing, and Biosimilars
AMA and EMA Issue Joint Guidance on Bundibugyo Ebola Vaccine Clinical Trial Requirements
Mineralys Therapeutics Achieves Phase 3 Albuminuria and Blood Pressure Data for Lorundrostat in CKD Patients
Merck Gains Traditional FDA Approval for Pembrolizumab
Latest news
11 storiesGenentech Achieves KRAS Targeting Breakthrough, Raising New Oncology Manufacturing Challenges
Genentech's KRAS breakthrough creates formulation and process validation challenges for oncology CDMOs and plant operations teams.
FDA Launches NAIN Initiative to Coordinate CNS Product Review Across CBER
FDA's NAIN initiative aligns CBER, CDER, and CDRH on CNS product development, launching with an Alzheimer's Prevention Accelerator.
AbbVie 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
Insmed has secured PMDA approval in Japan for BRINSUPRI, its DPP1 inhibitor for bronchiectasis, expanding the therapy's global commercial footprint.
FDA Grants Ultomiris Accelerated Approval for IgA Nephropathy
Alexion's complement inhibitor Ultomiris receives FDA accelerated approval for IgA nephropathy, marking a new treatment option for patients with this progressive kidney disease.
Novartis Wins EU Approval for Cosentyx in Polymyalgia Rheumatica
The European Medicines Agency has approved Novartis's secukinumab (Cosentyx) for polymyalgia rheumatica, delivering the first novel therapy for the inflammatory condition in more than 50 years and expanding the IL-17A inhibitor's already broad rheumatology portfolio.
AbbVie 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
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.
Worth your time this week
Unicycive Gains FDA Acceptance for OLC NDA Resubmission
Abbott Plans to Spin Off Its $8.5B Nutrition Business by 2027
Olympus Faces FDA Import Alert Over Quality System Violations
