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NewsNovartis India Appoints Dr. Chetan P. as Head of Medical, Regulatory and Pharmacovigilance
Novartis India consolidates medical, regulatory, and pharmacovigilance functions under Dr. Chetan P. amid tightening CDSCO post-market surveillance requirements.
Hearzap Acquires Amplifon India's Hearing Healthcare Business in Strategic Consolidation Move
Tianjin Kilo Pharmaceutical Receives FDA Warning Letter After Remote Records Review
Safrel Pharmaceuticals Receives FDA Warning Letter Citing Quality Unit Collapse Across OTC Drug Operations
Propanc Biopharma Initiates Feasibility Assessment for PRP in Advanced Solid Tumors
Latest news
11 storiesFibroBiologics Achieves Cartilage Repair in Preclinical Study Using Four-Day Chondrocyte Spheroid Process
FibroBiologics reports cartilage repair in four weeks from a single FSdCS injection, with a four-day manufacturing cycle drawing process development attention.
FDA Opens Public Comment on Generative AI Medical Device Regulation, Signaling Broader Framework Ahead
FDA's GenAI medical device discussion paper introduces risk and premarket frameworks QA and RA teams in pharma should track closely.
Biocon Gains FDA Approval for Yesintek Ustekinumab Prefilled Autoinjector in U.S. Market
Biocon secures FDA approval for Yesintek ustekinumab-kfce in prefilled autoinjector format, extending its U.S. biosimilar device portfolio.
Coultreon Biopharma Appoints Prista Charuworn As CMO
Coultreon Biopharma names Prista Charuworn, MD as CMO to lead COL-5671 into Phase II trials for ulcerative colitis and psoriasis.
Biocon Wins FDA Nod for Yesintek Autoinjectors in US
Biocon secures FDA approval for Yesintek prefilled autoinjectors, expanding the ustekinumab biosimilar's delivery formats and combination product regulatory scope.
FDA, CDC Reaffirm Vaccine Manufacturers’ VAERS Reporting Duties
FDA and CDC reaffirm mandatory VAERS reporting obligations for vaccine manufacturers under CBER post-market surveillance requirements.
FDA & CDC Clarify VAERS Reporting Duties Under NCVIA
FDA and CDC reissue VAERS guidance, reinforcing NCVIA mandatory reporting obligations for vaccine manufacturers and post-market surveillance teams.
Emergent BioDefense Gains FDA Nod For CYFENDUS Anthrax Vaccine
FDA has licensed CYFENDUS for anthrax post-exposure prophylaxis using animal-only efficacy data, setting a regulatory benchmark for biodefense biologics.
FDA Reaffirms HCT/P E-Registration Rules for Tissue Establishments
FDA outlines mandatory eHCTERS registration, annual December updates, and 30-day amendment windows for HCT/P establishments under 21 CFR Part 1271.
FDA Ends Export Certificate Notarization, Moves Biologics To BECATS
CBER ceased notarizing export certificates in 2014; regulatory teams should confirm BECATS submission workflows and State Dept. apostille routes for destination markets.
CBER Advances Global Biologics Strategy Through ICH And APEC
CBER's active roles in ICH and APEC RHSC are reshaping how biologics manufacturers approach multi-market regulatory alignment.
Worth your time this week
Optimus Pharma Gains First-in-India DCGI Approval for Tapinarof Cream 1% in Dermatology
Artelo Biosciences Secures U.S. Patent Allowance for ART27.13 Commercial Formulation Through 2041
Lupin Gains US FDA Approval for Generic Pitolisant Tablets Bioequivalent to Wakix
