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NewsViatris Launches Tender Offer to Acquire Pacira BioSciences for $36.50 Per Share
Viatris commences $36.50/share tender offer for Pacira BioSciences, with liposomal manufacturing integration posing key GMP and quality system implications.
EMA PRAC Launches Class-Wide Review of Human Normal Immunoglobulins
FDA Reinforces Risk-Based Inspection Model Across All U.S. Drug Manufacturing Sites
FDA Advances FRAME and AMTDP to Regulate Continuous, AI-Driven Drug Manufacturing
Celularity Signs Exclusive Deal with Vesalius Longevity Labs
Latest news
11 storiesFDA 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FDA Draft Guidance Sets Drug Delivery Data Standards
FDA draft guidance defines drug delivery performance data requirements for combination products across investigational, marketing, and post-market submissions.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.
FDA Confirms RX7 Articulaciones Contains Undeclared Drugs
FDA lab analysis confirms RX7 Articulaciones contains undeclared diclofenac and dexamethasone, raising supply-chain and labeling compliance concerns.
FDA Confirms Three Undeclared Drugs in Ort-Flx Pain Product
FDA lab analysis confirms Ort-Flx contains undeclared diclofenac, dexamethasone, and methocarbamol, triggering MedWatch reporting obligations.
Azora Therapeutics Appoints New Executive Team to Advance AT177
Azora Therapeutics rebrands from Adial Pharmaceuticals and names new leadership as AT177 Phase 1 targets H1 2027.
FDA Biosimilar Tracker: 30+ Products Cleared Since Mid-2024
FDA has cleared 30-plus biosimilars since mid-2024, spanning denosumab, ranibizumab, insulin aspart, and oncology biologics.
FDA Refreshes Drug Approvals Portal With 20+ Regulatory Tools
FDA consolidates 20+ regulatory databases on one page, covering REMS, Orange Book, drug shortages, and postmarketing commitments.
FDA Cures Act Expands EUA Powers and MCM Review Vouchers
The 21st Century Cures Act grants FDA authority to waive cGMP requirements under EUAs and establishes a priority review voucher program for MCM manufacturers.
FDA Reissues Tropical Disease Priority Review Voucher Guidance
FDA reissues guidance on tropical disease priority review vouchers under FDAAA section 524, clarifying eligibility and award criteria for sponsors.
Worth your time this week
Benitec Reports 100% Response Rate in BB-301 OPMD Trial
Teva Acquires BioXcel's BXCL501 Assets for At-Home Treatment
Sudeep Pharma Gains FDA Approval for Nandesari Gujarat Facility
