FDA
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.
It is also a milestone for the immunoglobulin A nephropathy (IgAN) community, as TARPEYO becomes the first and only FDA-approved treatment to reduce proteinuria in this condition.
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.