Approved – Talk Bio

Moderna’s COVID Vaccine Wins FDA Approval for At-Risk Young Children

2 days ago talkbio0Tagged Approved, At-Risk, Child, conditions, Covid Vaccine, Moderna, Spikevax, United States Food and Drug Administration

Moderna; FDA approval; COVID vaccine; children; at-risk; Spikevax; underlying conditions; full approval

Novartis Gains World-First Approval of Malaria Treatment for Babies

4 days ago talkbio0Tagged Africa, Approved, artemether-lumefantrine, Coartem, Infant, Infant, Newborn, Malaria, Novartis, Swissmedic, venture

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 weeks 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

3 weeks 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

3 weeks 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

3 weeks 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

4 weeks 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

4 weeks 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

FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

1 month ago talkbio0Tagged AdComm vote, Approved, chemo-turned-gel drug, Clinical Trials, ENVISION, intermediate-risk, low-grade, mitomycin, muscle-invasive bladder cancer, Negative, NON Mouse, ODAC, Sustained-release Mitomycin C Hydrogel Formulation UGN-102, United States Food and Drug Administration, UroGen, ZUSDURI

UroGen; FDA approval; ZUSDURI; UGN-102; chemo-turned-gel drug; mitomycin gel; low-grade intermediate-risk non–muscle-invasive bladder cancer; negative AdComm vote; ENVISION trial; ODAC

Nuvation Bio Scores First FDA Approval for Oral Lung Cancer Drug Ibtrozi

1 month ago talkbio0Tagged Approved, Bio, IBTROZI, Malignant neoplasm of lung, Nuvation, Oral treatment, Protein-tyrosine kinase inhibitor, ROS1-positive NSCLC, taletrectinib, United States Food and Drug Administration

Nuvation Bio; FDA approval; Ibtrozi; taletrectinib; lung cancer; ROS1-positive NSCLC; oral treatment; tyrosine kinase inhibitor