Approved – Page 3

Novartis; malaria; Coartem Baby; Swissmedic; newborns; infants; Africa; approval; artemether-lumefantrine; Medicines for Malaria Venture; not-for-profit

Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

2 months ago talkbio0Tagged Approved, concerns, COVID19 (disease), delays, Intact, Interferes with, Novavax, political, Regulation of biological process, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference

Gilead Wins Groundbreaking FDA Approval for Twice-Yearly HIV Prevention Shot

2 months ago talkbio0Tagged Approved, Gilead, Guidelines, HIV Prevention, Lenacapavir, Long-acting injectable, PREP gene, twice-yearly injection, United States Food and Drug Administration, World Health Organization, Yeztugo

Gilead; FDA approval; lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; long-acting injectable; WHO guidelines

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

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

Moderna Wins Expanded FDA Approval for RSV Vaccine in At-Risk Younger Adults

3 months ago talkbio0Tagged Adult, Approved, At-Risk, chronic health conditions, expanded label, Moderna, mRESVIA, RSV vaccine, United States Food and Drug Administration

Moderna; RSV vaccine; FDA approval; mRESVIA; at-risk adults; 18 to 59 years; expanded label; chronic health conditions