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NewsGranules India Completes USFDA Inspection at Gagillapur with 11 Observations Issued
Granules India's Gagillapur facility received 11 USFDA observations; the company confirms no data integrity or cross-contamination findings.
Zydus Appoints Christoph Stoller as President and Business Unit Head for International Markets
Alembic Pharmaceuticals Gains USFDA Final Approval for Venetoclax Tablets in CLL/SLL
Sun Pharma Gains FDA Approval for ILUMYA Expansion into Psoriatic Arthritis Indication
FDA Funds Digital Biomarker Validation Projects Targeting Wearable Endpoints
Latest news
11 storiesFDA Grants Accelerated Approval for Voceryq, First Plasmid DNA-Based Immunotherapy
FDA grants accelerated approval for Voceryq, the first plasmid DNA-based immunotherapy in the U.S., raising immediate GMP and CBER inspection implications.
FDA Updates Minocycline Susceptibility Breakpoints for Stenotrophomonas maltophilia Labeling Alignment
FDA updates minocycline breakpoints for Stenotrophomonas maltophilia; regulatory teams must review labeling alignment with new MIC and disk diffusion thresholds.
Viatris Launches $1.65B Tender Offer for Pacira BioSciences
Viatris commences $36.50/share tender offer for Pacira BioSciences, with liposomal manufacturing integration posing key GMP and quality system implications.
EMA PRAC Opens Class-Wide Review of Human Immunoglobulin Safety
EMA PRAC opens class-wide review of human normal immunoglobulins after batch-linked hypersensitivity clusters prompt recalls across EU Member States.
FDA Reinforces Risk-Based Inspections Across U.S. Drug Plants
FDA's risk-based inspection model applies to all U.S.-market drug manufacturers; QA teams must align CGMP readiness with both surveillance and for-cause inspection triggers.
FDA Advances FRAME and AMTDP for AI-Driven Drug Manufacturing
FDA's FRAME initiative and AMTDP define regulatory pathways for continuous manufacturing, distributed production, and AI-driven processes under CDER oversight.
Celularity Signs Exclusive Deal with Vesalius Longevity Labs
Celularity will finish-manufacture Vesalius's Peptual peptide APIs at its New Jersey facility under cGMP, ahead of anticipated FDA compounding rulemaking.
FDA Opens eCTD v4.0 Sample Submission Pathway for Drug Sponsors
FDA's eCTD v4.0 sample submission program lets sponsors validate technical conformance before official filing, with feedback typically within 30 days.
FDA Draft Guidance Sets Drug Delivery Data Standards
FDA draft guidance defines drug delivery performance data requirements for combination products across investigational, marketing, and post-market submissions.
FDA Activates eCTD v4.0 Forward Compatibility for Drug Filings
FDA activates eCTD v4.0 Forward Compatibility for NDAs, ANDAs, BLAs, and INDs from October 16, 2026, opening migration from v3.2.2.
Insmed Gains FDA Priority Review for ARIKAYCE sNDA
Insmed secures FDA Priority Review for ARIKAYCE sNDA and launches BRINSUPRI in Japan as the first MHLW-approved NCFB treatment.
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FDA Confirms RX7 Articulaciones Contains Undeclared Drugs
FDA Confirms Three Undeclared Drugs in Ort-Flx Pain Product
Azora Therapeutics Appoints New Executive Team to Advance AT177
