We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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 by the Demodex mite. Read More
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 clinical trials. Read More
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 from CDER’s Office of Compliance (OCC). Read More
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). Read More
The approval was supported by positive data from two pivotal studies in which patients showed significant improvement in the disease over those who received a placebo. Read More
The disappointing results “do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” said Pfizer CEO Albert Bourla. Read More
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) standard. Read More
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 Dec. 7, in which the company attributed some of its data deficiencies to a cyberattack. Read More
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. Read More