For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, ...

CEO Richard Francis reflects on Teva’s return to growth during his tenure, and what’s next for the drugmaker in its quest to ...

Positive outcomes from scientific advice meetings with the FDA and the EMA, were followed by a Simultaneous ... generating high healthcare costs. National guidance for labor induction have recently ...

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on delivering therapeutics through effective oral delivery, announced today that it has received revised regulatory guidance for LPCN ...

The FDA announced its draft guidance on recommendations for studies ... Panelists at an FDA Medical Devices Advisory Committee meeting in 2022 previously pointed out that pulse oximeters show ...

The Food and Drug Administration, a federal agency of the ... published virtually every Thursday for decades, detailing agency guidance, updates on disease outbreak investigations and studies ...

The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food contamination investigations.

Robert F. Kennedy Jr’s confirmation hearings began Wednesday before the Senate Finance Committee. He appears before the ...

FDA Supports Accelerated Clinical Development Strategy During the pre-IND meeting, the FDA provided ... This positive guidance positions Novamigra Tx to progress rapidly. After completing ...

FDA’s guidance emphasizes the importance of transparency ... s AI experts and in-house counsel to ensure a sponsor is meeting all of FDA’s requirements to move a product to market.