FDA To Decide On Agios' Request For Expanded Approval Of PYRUKYND In Thalassemia By September 7.
Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
Healio1h
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
Cure Today3d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
Hosted on MSN20h
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.
First-of-Its-Kind Parkinson’s Patch at Center of Fight Over FDA Approval of Generic Version
New Jersey-based pharmaceutical company UCB has sued to protect its patents for a Parkinson’s drug after an India-based ...
Business Wire8d
Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of R…
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, ...
Solid Biosciences stock jumps 11% post-market on FDA update
Shares of Solid Biosciences (NASDAQ:SLDB) jumped 11% post-market after the company said the FDA had cleared an ...
Nasdaq8d
Corcept Therapeutics submits relacorilant new drug application to FDA
Corcept Therapeutics (CORT) has submitted a new drug application to the FDA for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism.
Cure Today3d
FDA Reviews NDA for Dordaviprone in Recurrent H3 K27M-Mutant Diffuse Glioma
Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...
Targeted Oncology4d
FDA Reviews NDA for Dordaviprone in H3K27M-Mutant Diffuse Glioma
A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma ...
Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma
This NDA submission marks a pivotal moment for Chimerix in our mission to bring this potentially life-altering drug to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma,” said Mike ...