United States Food and Drug Administration
FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews
FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing
Recent Advances and News in In Vivo Therapeutic Technologies (2025)
in vivo CAR-T; cell therapy; gene therapy; RNA delivery; autoimmune disease; oncology; nanoparticle delivery; drug delivery innovation; FDA fast track; biotech acquisitions
White House Announces New Most-Favored Nation Drug Pricing Deal, Updates on FDA Vouchers and GLP-1 Negotiations
most-favored nation pricing; fertility drugs; IVF; Trump administration; drug pricing; Medicaid; FDA vouchers; GLP-1; EMD Serono; Pfizer; AstraZeneca
Krystal Biotech Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for Neurotrophic Keratitis
Krystal Biotech; FDA; platform technology designation; HSV-1 viral vector; KB801; gene therapy; neurotrophic keratitis; redesable eye drop; VYJUVEK
Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction
Canal Row Advisors; FDA leadership; regulatory consulting; Michael Rogers; Hilary Marston; life sciences; regulatory strategy; public health; FDA reform; innovation policy
Are the Good Times in Biotech Back? – Insights from Post-Hoc Live’s 2025 Industry Sentiment
biotech sentiment; Post-Hoc Live; 2025 industry outlook; biotech M&A; FDA delays; executive survey; public biotech companies; JP Morgan effect; biotech funding
Former FDA Deputy Dr. Namandjé N. Bumpus to Lead Charles River’s New Scientific Advisory Board
Namandjé Bumpus; Charles River Laboratories; Scientific Advisory Board; FDA; New Approach Methodologies; NAMs; alternative testing; drug development; animal welfare; biopharmaceutical innovation
Unlocking Access: Navigating Pharma’s Regulatory Crossroads – Recent Updates (2025)
pharmaceutical regulation; market access; drug pricing; FDA transparency; biosimilars; executive actions; market access strategy; drug importation; CRLs; patient access
Spotlight On: Cabaletta Bio’s Small but Mighty Breakthrough for CAR-T in Autoimmune Arena
Cabaletta Bio; CAR-T therapy; rese-cel; autoimmune diseases; B cell depletion; myositis; systemic lupus erythematosus; systemic sclerosis; pemphigus vulgaris; preconditioning; clinical trial; FDA
FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months
FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval