GlaxoSmithKline (GSK) has prevailed over six other bidders with its $1.9 billion offer to purchase Sierra Oncology, gaining the Canadian company’s promising investigational Janus kinase (JAK) inhibitor, momelotinib, for the…
Tarsus Pharmaceuticals’ a New Drug Application (NDA) for TP-03 (lotilaner ophthalmic solution, 0.25%) later this year based on positive phase 3 results for its investigative treatment for eyelid infections caused…
The FDA has turned down a citizen petition seeking that the investigators and the institutional review board (IRB) at Minneapolis, Minn.-based Hennepin County Medical Center (HCMC) be barred from conducting…
In 2021, the FDA’s Center for Drug Evaluation and Research (CDER) issued fewer warning letters but conducted moregood clinical practice inspections that the previous year, according to the annual report…
The FDA is convening far fewer advisory committee meetings and it often chooses not to follow their advice, according to a new analysis. Source: Drug Industry Daily
Aduhelm’s long and tortuous developmental pathway appears to have hit its final, insurmountable obstacle, with developer Biogen officially abandoning the first-ever-approved antiamyloid antibody for the treatment of Alzheimer’s disease (AD).…
The FDA has released four related final guidances to help drugmakers submit electronic safety reports — including advice on how to conform to the latest International Council for Harmonization (ICH)…
The FDA issued a Form 483 with nine observations to generics manufacturer Aurolife Pharma following a six-week inspection of the company’s manufacturing facility in Dayton, N.J., from Oct. 25 through…
The FDA has placed a clinical hold on the phase 1/2 study of Vertex Pharmaceuticals’ investigational stem cell-derived therapy for type 1 diabetes. Source: Drug Industry Daily
Complete Response Letters (CRLs) from the FDA have determined different fates for two chemotherapeutic agents tested in China. Source: Drug Industry Daily