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NewsMankind Pharma Appoints Sandeep Joshi as Associate Vice President of International Business
Mankind Pharma names Sandeep Joshi AVP of International Business, signaling continued investment in regulated-market export leadership.
Gland Pharma Appoints Deepak Sapra as CEO Amid Global Injectable Expansion
Teva Gains FDA Priority Review for Ecopipam NDA Targeting Pediatric Tourette Syndrome
FDA CBER Issues Potency Assessment Guidance for Active Immunotherapy CGT Products
IDEAYA Biosciences Signs Clinical Collaboration with Genentech for IDE892 in MTAP-Deleted PDAC
Latest news
11 storiesNovartis Presents 10 Cardiovascular Abstracts at ESC 2026, Including Phase IV Inclisiran and Abelacimab Data
Novartis Presents 10 Cardiovascular Abstracts at ESC 2026
Novartis 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.
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Hearzap Acquires Amplifon India's Hearing Healthcare Business in Strategic Consolidation Move
Hearzap completes acquisition of Amplifon India's hearing healthcare business, expanding its clinic network and triggering full operational integration.
Tianjin Kilo Pharmaceutical Receives FDA Warning Letter After Remote Records Review
FDA issues warning letter to Tianjin Kilo after 704(a)(4) remote review finds CGMP violations and drug listing failures at Chinese API facility.
Safrel Pharmaceuticals Receives FDA Warning Letter Citing Quality Unit Collapse Across OTC Drug Operations
FDA's August 2026 warning letter to Safrel Pharmaceuticals details a full quality unit collapse: no CoAs, no supplier agreements, no warehouse controls.
Propanc Biopharma Initiates Feasibility Assessment for PRP in Advanced Solid Tumors
Propanc Biopharma engages Avance Clinical for Phase 1b PRP feasibility assessment, targeting a CTA submission in Q4 2026 across Australian trial centers.
FibroBiologics 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.
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 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.
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.
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FDA, CDC Reaffirm Vaccine Manufacturers’ VAERS Reporting Duties
FDA & CDC Clarify VAERS Reporting Duties Under NCVIA
Emergent BioDefense Gains FDA Nod For CYFENDUS Anthrax Vaccine
