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NewsCronus Pharma Wins FDA Nod for Generic Robenacoxib Injection
Cronus Pharma secures FDA approval for a generic Robenacoxib injection, entering the veterinary NSAID injectable market under full GMP compliance requirements.
Propanc Reports Over 90% Tumor Inhibition for PRP
Verrica Completes COVE-2 Enrollment for YCANTH
Abbott Wins CE Mark for Amulet 360 LAA Occluder
Cormica Publishes FDA Compounding Enforcement Roadmap
Latest news
11 storiesSanofi Gains Updated FDA Approval for TENIVAC Vaccine
FDA issued an updated approval letter for Sanofi's TENIVAC Td vaccine on August 26, 2026, requiring regulatory teams to review revised labeling and compliance documentation.
Moleculin Hits Enrollment Milestone in Relapsed AML Trial
Moleculin's MIRACLE trial nears a 90-patient interim analysis for Annamycin in R/R AML, a key checkpoint on the FDA-aligned path to registration.
Nicox Secures April 2027 PDUFA Date for NCX 470 Glaucoma Drug NDA
FDA accepts Nicox's NCX 470 NDA and sets a 30 April 2027 PDUFA date, with U.S. launch targeted H2 2027.
AbbVie Submit EMA Application for Risankizumab in Crohn’s Disease
AbbVie files with EMA for risankizumab SC induction in Crohn's disease, backed by Phase 3 AFFIRM data from 289 patients.
Revolution Medicines Wins FDA Approval for Daraxonrasib in mPDAC
FDA approves Revolution Medicines' daraxonrasib for metastatic pancreatic adenocarcinoma, using RTOR and Project Orbis, 6.5 months ahead of goal date.
Priovant Publishes Phase 3 Brepocitinib Skin Outcomes
Priovant's VALOR trial skin data, published in JAMA Dermatology, strengthens the brepocitinib evidence package ahead of a potential NDA/BLA submission.
Revolution Medicines Wins FDA Approval for Daraxonrasib
Revolution Medicines' daraxonrasib approved 6.5 months early, signaling what Breakthrough Therapy designation and the National Priority Voucher pilot can do for oncology CMC timelines.
Baxter Recalls Two Sodium Chloride Lots Over Fiberglass
Baxter recalls two VIAFLEX lots of 0.9% Sodium Chloride Injection over fiberglass particulate contamination, distributed across 14 U.S. states.
Aurigene Signs Long-Term Deal Covering 20+ Drug Products Globally
Aurigene signs a long-term CDMO deal covering 20+ sterile injectables, biologics, and topicals for global supply from its India facilities.
Cipla Pithampur Facility Gets 7-Observation Form 483 From USFDA
Cipla's Pithampur site received a seven-observation Form 483 after a USFDA follow-up inspection concluding August 25, 2026.
Ascendis Presents Week 104 Approach Trial Data for YUVIWEL
Ascendis Pharma presents 104-week ApproaCH Trial data for navepegritide at ISDS 2026, ahead of an anticipated EMA decision in Q4 2026.
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