ORG
Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos
Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis
United Therapeutics’ Tyvaso Succeeds in Phase 3 IPF Trial, Marking Major Advance in Lung Disease Treatment
Tyvaso; United Therapeutics; idiopathic pulmonary fibrosis; IPF; Phase 3 trial; TETON-2; lung disease; forced vital capacity; FVC; clinical trial; FDA; nebulized treprostinil
Ionis Posts Strong Results for Tryngolza in Severe Blood Fat Disease
Ionis Pharmaceuticals; Tryngolza; olezarsen; hypertriglyceridemia; triglycerides; Phase III Essence study; FDA approval; familial chylomicronemia syndrome; cardiovascular risk reduction; drug launch
Genentech (Roche) Signs $420 Million Deal With OMass Therapeutics for Preclinical IBD Program
Genentech; Roche; OMass Therapeutics; inflammatory bowel disease (IBD); preclinical program; biotech partnership; OdyssION platform; small molecule therapy; drug discovery; milestone payments
AstraZeneca gears up for FDA filing after baxdrostat’s phase 3 hypertension success
AstraZeneca; baxdrostat; hypertension; FDA filing; aldosterone synthase inhibitor; phase 3 trial; regulatory approval
Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile
Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity
Zenas BioPharma Secures $300M Royalty Deal for Obexelimab FDA Approvals
Zenas BioPharma; Royalty Pharma; Obexelimab; autoimmune diseases; IgG4-Related Disease; Systemic Lupus Erythematosus; FDA approval; royalty agreement; Phase 3 INDIGO trial; funding
Fierce Biotech Fundraising Tracker ’25: CHARM attracts $80M; Wugen reels in $115M
CHARM Therapeutics; AI drug design; menin inhibitor; acute myeloid leukemia (AML); Series B funding; venture capital; biotech fundraising; Wugen; NVIDIA; drug development
Teva Launches First Generic GLP-1 Weight-Loss Drug in the US
Teva; GLP-1; generic; weight loss; liraglutide; FDA approval; Saxenda; obesity treatment; United States
J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results
Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases