FDA
To give the FDA more time to evaluate updates to quizartinib’s proposed REMS program, the regulator is pushing the target action date to July 24.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The FDA said Orencia is the first drug approved as prophylaxis for aGVHD prevention that included real-world evidence as one component of clinical efficacy.
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
The latest warning letter asks Medtronic to update its systems and procedures in order to deliver safe and high-quality devices to consumers.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
The FDA said that it is not authorizing molnupiravir’s use during pregnancy as there are hardly any clinical scenarios where the benefits appear to outweigh the risks.
Novartis has grown weary of waiting, dropping out of its deal to fund Mesoblast’s floundering COVID-19 treatment.
BrainStorm Cell Therapeutics is making a strong comeback after the FDA was a little impressed with Phase III results of amyotrophic lateral sclerosis treatment.
Shares of Reata Pharmaceuticals have plunged nearly 40% in premarket trading after an FDA advisory panel recommended against the approval of its Alport syndrome disease treatment, bardoxolone.
The regulatory agency just placed new safety warnings on that drug class, which will impact AbbVie’s Rinvoq (upadacitinib), a drug the company has seen as a successor to its revenue-driving Humira.
The approval of Keytruda also now includes stage III melanoma following complete resection for pediatric patients 12 years and up.