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NewsFDA Office of Health Advancement Issues Guidance Shaping Regulatory Expectations
FDA's OHA has structured a 2025 guidance agenda covering combination products, rare disease incentives, and clinical trial oversight.
Moderna Achieves Phase 2/3 Recommendation for mRNA Ebola Vaccine
MaaT Pharma Achieves Primary Safety Endpoint in PICASSO Trial
FDA Publishes 2024 ANDA Data Showing 720 Approvals Amid Sustained Generic Pricing Pressure
Rigel Pharmaceuticals Launches VEPPANU as First FDA-Approved PROTAC Therapy
Latest news
11 storiesJanssen Gains FDA Accelerated Approval for Rybrevant Faspro
FDA grants Janssen accelerated approval for subcutaneous Rybrevant Faspro in platinum- and checkpoint inhibitor-refractory HNSCC under Project Orbis.
Cabaletta Bio Targets 1Q28 BLA Submission for Rese-cel
Cabaletta Bio targets a Q1 2028 BLA submission for rese-cel, citing standardized CAR-T manufacturing and weight-based dosing as core to its regulatory strategy.
Allogene Therapeutics Advances ALPHA3 Enrollment Globally with Expansion in 1L LBCL Trial
Allogene's ALPHA3 Phase 2 trial expands into Asia-Pacific, raising GMP and supply chain demands for allogeneic CAR-T manufacturing at scale.
Lantheus Merges with Curium in $8 Billion Deal After Dual FDA Approvals
Lantheus and Curium's $8B merger, paired with dual FDA approvals, sets a complex GMP and supply-chain integration challenge for radiopharmaceutical operations.
FDA Launches Rare Disease Framework Initiative to Reshape Orphan Drug Review Pathways
FDA's Rare Disease Framework Initiative introduces fit-for-purpose review models for orphan drugs, with direct implications for regulatory and QA teams.
Viatris Advances Pacira Acquisition as Innovative Medicines Pivot
Viatris targets a November 2026 close for its Pacira BioSciences acquisition as dual regulatory approvals reinforce its innovative medicines strategy.
Telix Joins Thera4Care Consortium to Advance FAP-Targeted Therapy
Telix joins Thera4Care to clinically evaluate its FAP-targeting dimer with terbium-161, raising new GMP and supply chain questions for radiopharmaceutical manufacturers.
Bayer Wins China First-Line Approval for Sevabertinib in NSCLC
Bayer's sevabertinib receives China first-line approval for HER2-mutated advanced NSCLC, raising scale-up and GMP compliance priorities for regional manufacturers.
Evotec Wins Vertex Commercial Manufacturing Role for Povetacicept
Evotec's J.POD Redmond facility secures a commercial manufacturing role for Vertex's povetacicept, marking a key milestone for its continuous biologics platform.
Alembic Expands DifGen Partnership for US Complex Generics
Alembic Pharma partners with DifGen to develop and manufacture complex generics in the US, reducing FDA inspection risk on foreign-made products.
Fresenius Teams With WuXi on 66-Molecule Biosimilar Pipeline
Fresenius and WuXi Biologics strike a deal expanding the biosimilar pipeline to 66 molecules, with Fresenius retaining all global marketing authorizations.
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