Priority Review – Talk Bio

FDA Announces First Recipients of Makary’s National Priority Voucher Program, Expanding Scope for Accelerated Drug Reviews

1 week ago talkbio0Tagged Accelerated, CNPV, domestic drug manufacturing, Drug Approval, Martin Makary, National Priority Voucher, pilot program, Priority Review, public health crisis, recipients, United States Food and Drug Administration

FDA; National Priority Voucher; CNPV; Martin Makary; priority review; accelerated drug approval; 2025 pilot program; voucher recipients; public health crisis; domestic drug manufacturing

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

3 months ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

FDA Grants Dupixent (Dupilumab) Eighth Approval: Now Cleared for Bullous Pemphigoid

4 months ago talkbio0Tagged Approved, Autoimmune Diseases, Bullous pemphigoid, Drugs, Orphan, dupilumab, Dupixent, Priority Review, Regeneron, sanofi, type 2 inflammation, United States Food and Drug Administration

Dupixent; Dupilumab; Sanofi; Regeneron; bullous pemphigoid; FDA approval; type 2 inflammation; autoimmune disease; priority review; orphan drug

Bavarian Nordic Sells FDA Priority Review Voucher for $160M Amid Rising Industry Prices and Program Scrutiny

4 months ago talkbio0Tagged Bavarian Nordic, biotech finance, chikungunya vaccine, NIH Mouse, Priority Review, Sales - occupational activity, United States Food and Drug Administration, Vimkunya

Bavarian Nordic; Priority Review Voucher; FDA; voucher sale; $160 million; chikungunya vaccine; VIMKUNYA; NIH; antitrust review; biotech finance

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

4 months ago talkbio0Tagged Accelerated, Biopharma, CNPV, Drug Approval, national priorities, Priority Review, public health medicine (field), Review [Publication Type], United States Food and Drug Administration, unmet

FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs

Otsuka’s Phase 3 IgAN Win with Sibeprenlimab Shakes Vera’s Stock

5 months ago talkbio0Tagged IGA Glomerulonephritis, Kidney Diseases, Otsuka, Priority Review, Proteinuria, Sibeprenlimab, stock drop, United States Food and Drug Administration, UPCR, vera

Otsuka; sibeprenlimab; IgA nephropathy; phase 3 trial; proteinuria reduction; Vera Therapeutics; stock drop; kidney disease; UPCR; FDA Priority Review

FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC

11 months ago talkbio0Tagged ADRIATIC, Approved, Breakthrough Therapy, durvalumab, Identifier, Imfinzi, Limited-stage, LS-SCLC, Phase 3 Clinical Trials, Priority Review, Systemic Immunotherapy, United States Food and Drug Administration

Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review