The FDA plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest ...
By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
WASHINGTON — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win ...
In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.
GlobalData on MSN
NG Biotech announces FDA approval for diagnostic assays
NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.
New drugs were approved for the oncology field, and for treating ophthalmic, gastrohepatic, hemologic, and metabolic disorders.
Gadget Review on MSN
Magic mushroom treatment takes a big step toward FDA approval – here's what changed
Compass Pathways' synthetic psilocybin COMP360 clears Phase 3 trials, showing 39% depression reduction in 24 hours for treatment-resistant patients.
Cardiac amyloidosis is a progressive condition that affects the heart and other organs, but new FDA-approved drugs are prolonging the lives of those affected and early identification is now possible.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results