CEO Dave Rosa today issued a letter to shareholders outlining the company’s exposure to tariff impact. Tariffs recently ...

The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...

We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several ...

The nonprofit Physicians Committee for Responsible Medicine, which promotes the use of human-relevant test methods to replace ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative glaucoma surgical system, Leos TM (Laser Endoscopy Ophthalmic System ...

The FDA is planning to take an additional three months to review Biogen's experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April.

Nanox Imaging Ltd. has received FDA 510(k) clearance for its new Nanox.ARC X multi-source digital tomosynthesis system, marking the first FDA approval for this technology for general use in ...

DENVER, April 17, 2025 /PRNewswire/ -- Imidex, a Denver-based leader in artificial intelligence for healthcare, today announced the sale of its FDA-cleared AI algorithm, VisiRad ® XR, along with ...

The FDA's decision ... complete response letter (CRL) delivered this week, which said another trial would be required to support approval. GlobalData's Nancy Jaser said the decision is a blow ...

Regarding "With deadlines approaching, Missouri’s new paid sick leave law in limbo" (April 15): It is reckless for the Missouri Legislature to try to throw the voters' decision in passing ...