Priority Review – Talk Bio

FDA Breakthrough Designations Lead to Priority Reviews, Report Finds

3 weeks ago talkbio0Tagged biotechnology innovation, Breakthrough Therapy, CDER, Drug Approval, expedited pathway, Identifier, Infrequent, Neoplasms, Priority Review, regulatory science, United States Food and Drug Administration

FDA; breakthrough therapy designation; priority review; drug approval; expedited pathway; biotechnology innovation; rare diseases; oncology; CDER; regulatory science

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

3 weeks ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

UCB Wins First FDA Approval for Ultra-Rare Mitochondrial Disease: Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

1 month ago talkbio0Tagged Approved, Breakthrough Therapy, doxecitine, doxribtimine, Drugs, Orphan, Infrequent, Kygevvi, Mitochondrial Diseases, Pediatric Disorder, Priority Review, Thymidine kinase 2 deficiency, TK2d, UCB, United States Food and Drug Administration

UCB; FDA approval; Kygevvi; mitochondrial disease; Thymidine Kinase 2 deficiency; TK2d; doxecitine; doxribtimine; rare diseases; Orphan Drug; Breakthrough Therapy; Priority Review; Rare Pediatric Disease

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

2 months 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

4 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

6 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

6 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

6 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

6 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

1 year 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