Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...

Medtronic has secured a green light from the FDA to connect its latest automated insulin pump with its newest continuous glucose monitor, following a similar approval for the pairing in Europe ...

Shortly before the warning letter was lifted, Medtronic received FDA approval for its 780G insulin pump, which had been under review since 2021. At the time, analysts with RBC Capital Markets said ...

The FDA granted the “breakthrough device” designation to the research group’s Damo Panda model, allowing for an expedited review and approval process, Alibaba said in a statement on Thursday.

as well as an FDA approval for its Opdivo® and Yervoy® combination for specific cancer treatments. Despite these positive regulatory advances, the company's stock experienced a 2.44% decline ...

A third player in the market, Novavax, filed for approval of a non-mRNA vaccine based on the earlier JN.1 variant before the FDA asked manufacturers to switch to KP.2. However, it said it is ...

Novo Nordisk (NYSE:NVO) has filed for U.S. approval of an oral version of its blockbuster weight loss drug Wegovy, the company confirmed to BioPharma Dive. The Danish drugmaker disclosed the ...

Approval by the European Commission generally follows a few weeks after a CHMP decision, and that situation contrasts with the US, where the FDA has just delayed the timeline for its verdict on ...

Regeneron Pharmaceuticals and Sanofi won U.S. Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic ...

Eli Lilly says it plans to submit orforglipron to the U.S. Food and Drug Administration for approval as a Type 2 diabetes treatment in 2026. For weight management, it plans to submit the drug to ...

The delays have caused widespread concern among ... “She hadn’t received approval for a writer and had to appear on her own. Thankfully, the examination centre’s principal stepped in and ...