United States Food and Drug Administration – Page 9

Inside the FDA’s Listening Tour: Officials Agree US Lags Behind China on Drug Development

2 months ago talkbio0Tagged Biotechnology, China, Clinical Trials, Drug Development, Drug Industry, innovation, Regulation, United States Food and Drug Administration

FDA; China; drug development; biotechnology; regulation; clinical trials; pharmaceutical industry; biotech innovation

FDA’s Top Cell and Gene Therapy Leaders Exit Amid CBER Upheaval

2 months ago talkbio0Tagged Anatol, biopharma regulation, CBER, Cell Therapy, Changing, gene therapy, Leadership, Nicole Verdun, Peter Marks, Rachael, United States Food and Drug Administration

FDA; cell therapy; gene therapy; CBER; Nicole Verdun; Rachael Anatol; Peter Marks; leadership changes; biopharma regulation

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

2 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

FDA Approves Gilead’s Twice-Yearly HIV Prevention Shot

2 months ago talkbio0Tagged Approved, Gilead Sciences, HIV Prevention, Lenacapavir, PREP gene, public health medicine (field), twice-yearly injection, United States Food and Drug Administration, Yeztugo

FDA approval; Gilead Sciences; Lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; public health

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

2 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

Genentech’s Kristin Bittenbender Named BIO Board Chair Amid Industry Challenges

2 months ago talkbio0Tagged Bio, biotech industry, Biotechnology, board chair, existential threats, genentech, Kristin Bittenbender, Leadership Change, Policy, United States Food and Drug Administration

BIO; Genentech; Kristin Bittenbender; board chair; biotech industry; FDA; existential threats; leadership change; biotechnology policy

FDA Launches New Priority Review Voucher Program Aligned with National Priorities

2 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

FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE

2 months ago talkbio0Tagged Andembry, Angioedemas, Hereditary, Approved, dosing, factor XIIa, garadacimab-gxii, Inhibitor, SMPX gene, Subcutaneous Injections, Takeda, Takhzyro, United States Food and Drug Administration

Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection

Second Patient Dies After Receiving Sarepta’s Elevidys Gene Therapy for DMD

2 months ago talkbio0Tagged AAV-based gene therapy, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Patient Death, risk mitigation, Unable to walk (finding), United States Food and Drug Administration

Duchenne muscular dystrophy; gene therapy; Sarepta Therapeutics; Elevidys; acute liver failure; AAV-based gene therapy; patient death; non-ambulatory patients; FDA; risk mitigation

FDA Delays Decision on KalVista’s HAE Drug Sebetralstat, Citing Heavy Workload

2 months ago talkbio0Tagged Angioedemas, Hereditary, constraints, Deferred, Drug Approval, KalVista, on-demand, Oral cavity, PDUFA, Resources, Sebetralstat, United States Food and Drug Administration

KalVista Pharmaceuticals; sebetralstat; FDA delay; hereditary angioedema; resource constraints; PDUFA date; drug approval; oral on-demand treatment