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NewsFDA Refreshes Drug Approvals and Databases Portal Across 20 Regulatory Tools
FDA consolidates 20+ regulatory databases on one page, covering REMS, Orange Book, drug shortages, and postmarketing commitments.
FDA's 21st Century Cures Act Reshapes EUA Authority and GMP Waiver Powers for MCM Manufacturers
FDA Reissues Tropical Disease Priority Review Voucher Guidance
Benitec Biopharma Achieves 100% Response Rate in BB-301 Study for OPMD
Teva Acquires BioXcel Assets to Advance First At-Home Acute Agitation Treatment
Latest news
11 storiesSudeep Pharma Gains FDA Approval for Nandesari Gujarat Facility
Sudeep Pharma secures FDA approval for its Nandesari, Gujarat facility, with US commercial supplies targeted for H2 FY27.
Jubilant Biosys Appoints Dr. SK Dhakshinamoorthy as Senior VP
Jubilant Biosys appoints Dr. SK Dhakshinamoorthy as Senior VP of Strategy and Value Creation, signalling a formalised capability expansion agenda.
FDA Renews Peripheral and CNS Drugs Advisory Committee
FDA has renewed the Peripheral and CNS Drugs Advisory Committee charter, resetting a two-year cycle governing neurological drug advisory reviews.
FDA Compliance Policy Guides Manual Signals Enforcement Priorities for Drug Plant Inspections
FDA's CPG manual directs investigator enforcement strategy, plant heads and QA directors should treat it as a pre-inspection compliance benchmark.
Amgen Receives FDA OPDP Warning Letter Over Misleading Vectibix Promotional Video
FDA's OPDP issued a warning letter to Amgen over a Vectibix promotional video, citing false or misleading risk presentation under 21 CFR 202.1.
FDA Flags NeilMed Glycerin Testing Failures in Warning Letter
FDA cited NeilMed Pharmaceuticals for glycerin identity testing failures and unqualified supplier use, flagging DEG/EG contamination risk in OTC drug manufacturing.
NeilMed Secures FDA Warning Letter Closeout After CAPA Recovery
FDA closes NeilMed Pharmaceuticals' 2023 Warning Letter but flags ongoing inspection oversight and sustained compliance expectations.
FDA Draft Guidance Addresses Individualized Genome Editing BLAs
FDA's CBER releases draft guidance on single-BLA submissions for individualized genome editing products, with comments due 27 November 2026.
Beaute Bounty Receives FDA CBER Warning Letter for Unlicensed Stem Cell and Placenta Biologics
FDA's CBER issued a warning letter to Malaysia-based Beaute Bounty for selling unlicensed stem cell and placenta biologics to U.S. consumers online.
FDA Warns Best Chinese Medicines LLC Over Five Unapproved Drugs
FDA cited Best Chinese Medicines LLC for marketing five unapproved drug products, flagging disease treatment claims across product pages and blog content.
Alembic Wins USFDA Approval for Valganciclovir Oral Solution
Alembic Pharmaceuticals receives USFDA final approval for Valganciclovir oral solution, indicated for CMV retinitis in AIDS patients.
Worth your time this week
AbbVie Submits FDA Application for Etentamig in Multiple Myeloma
World's Biggest Microbiology & CCS Summit ‘Pharmig India 2026’ Unites Global Microbiology & CCS Leaders in Hyderabad
BMS-Partnered Iza-Bren Doubles PFS in Phase 3 Lung Cancer Trial
