FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
GlobalData on MSN

FDA to allow one pivotal trial instead of two for drug approval

Prasad and Makary disagree that some may believe this move shows the FDA relaxing its standards.

US FDA approves Vanda's antipsychotic pill, shares climb

By Sneha S K and Kunal Das Feb 20 (Reuters) - The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' drug for the treatment of two serious mental health conditions, the company said ...

FDA Moves Toward Faster Drug Approvals

FDA Commissioner Dr. Marty Makary and his top deputy, Dr. Vinay Prasad, detailed the plan Feb. 18 in The New England Journal of Medicine. The move is the latest in a series of FDA efforts to eliminate ...
Morning Overview on MSN

Magic mushroom therapy just jumped closer to FDA approval

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for ...
Healio

First all-oral, fixed-duration combination regimen wins FDA approval for untreated CLL

The FDA has approved the first all-oral, fixed-duration first-line regimen for treatment of chronic lymphocytic leukemia and ...
CURE

FDA Approves Calquence Plus Venclexta for CLL and SLL

The Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) tablets and capsules in combination with Venclexta (venetoclax) for adults with chronic lymphocytic leukemia (CLL) or ...
The American Journal of Managed Care

FDA Approval of CLL Combo Marks New Era for Leukemia Care

FDA cleared acalabrutinib plus venetoclax as the only all-oral, fixed-dose combination option for first-line, treatment-naïve CLL/SLL. Phase 3 AMPLIFY showed superior PFS versus chemoimmunotherapy, ...
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.
Medscape

FDA Approves New Topical for Atopic Dermatitis

The FDA has approved topical difamilast for treating mild-to-moderate atopic dermatitis (AD) in adults and children aged 2 years or older, according to a press release from the manufacturer, Acrotech ...

FDA-Approved Drop XDEMVY Offers Targeted Relief for Demodex Blepharitis Patients, Modern Vision Solutions Reports

OMAHA, NE - January 22, 2026 - PRESSADVANTAGE - Modern Vision Solutions has announced the publication of a new article, ...

FDA chief warns US is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...