Healio

When aiming for FDA approval, “fight” when you are right

When navigating the FDA approval process, ophthalmologists must be ready to “fight” on behalf of their findings, according to ...
MedPage Today on MSN

Speeding Up Approvals, Getting More Drugs OTC Among FDA's Top Priorities

"We can do better," commissioner says ...
MobiHealthNews

FDA approval process too slow for wireless health

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

FDA approves new weight loss pill in record time

A new daily pill to help with weight loss has been approved by the U.S. Food and Drug Administration (FDA), and it moved ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
The American Journal of Managed Care

Higher-Dose Semaglutide Approved Under New FDA Accelerated Review Process

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight reduction under the FDA’s National Priority Voucher framework. STEP UP (n=1407) ...
Zacks Investment Research on MSN

Artivion secures FDA approval for NEXUS aortic arch system

Artivion, Inc. AORT recently announced that the FDA has approved the premarket approval application for the NEXUS Aortic Arch ...

PulsePatch™ Gains Strategic Backing Led by Retired First Responders, Advances Toward FDA Approval and National Expansion

This isn’t just innovation. It’s protection, accountability, and humanity for everyone involved.”— Jared BootheHOUSTON, ...