The day in pharma, read in minutes.
Hepion Pharmaceuticals Gains FDA Backing for GV104 Modeling
Hepion's GV104 nalmefene buccal film receives FDA affirmation of modeling-and-simulation NDA pathway for fentanyl prophylaxis.
FDA Extends Coral Snake Antivenin Lot CL6814 Expiration to June 2026 on Stability Data
Orchid Pharma Signs $80M Latin America Deal to Distribute Exblifep Across Nine Markets
Pfizer Reports Positive Phase 2 Results for 25-Valent Infant Vaccine
Artelo Biosciences Advances ART26.12 Into MAD Study
Latest news
11 storiesV-Shapes Single-Dose Packaging for Nutraceuticals, Skincare
V-Shapes promotes its patented snap-and-squeeze single-dose packaging for nutraceutical, skincare, dermatology and OTC brands.
IDEAYA Reports 17.4-Month Median Overall Survival in 2L 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 12 Biologics Guidance Documents Across Key Areas
FDA released twelve biologics guidance documents from July–October 2026, with container closure integrity and blood component manufacturing among the priority areas.
AMA and EMA Set Clinical Trial Guidance for Ebola Vaccines
AMA and EMA publish joint position paper setting minimum clinical trial requirements and toxicology waiver criteria for BDBV Ebola vaccine developers.
Mineralys Therapeutics Achieves Phase 3 Albuminuria and Blood Pressure Data for Lorundrostat in CKD Patients
Mineralys Therapeutics presents Phase 3 lorundrostat data showing BP and albuminuria reductions in CKD patients ahead of a December 2026 PDUFA date.
FDA Grants Traditional Approval for Keytruda in TMB-H Tumors
FDA converts pembrolizumab's TMB-H approval to traditional status, raising the biomarker threshold from ≥10 to ≥13 mut/Mb and narrowing patient eligibility.
Genentech 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 to Coordinate Neuroscience Product Review
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.
Worth your time this week
Novartis Wins EU Approval for Cosentyx in Polymyalgia Rheumatica
AbbVie Reports Higher Endoscopic Remission in Crohn’s Trial
Dr. Reddy's Gains DCGI Approval for Zytorvi in Esophageal Cancer
