The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS ...

"We believe retatrutide is a biologic application," Eli Lilly’s CEO Dave Ricks, MBA, told analysts on the company's second-quarter earnings call in August. The outcome will shape how long retatrutide ...

The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA ...

In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...

VTv Therapeutics said the Food and Drug Administration granted orphan drug designation to HPPD, which is being investigated as a treatment for sickle cell disease.

In the fourth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the Food and Drug Administration’s requirements and standards for approval of biosimilar ...

Newswise — SPOKANE, Wash., Aug. 25, 2026 -- Professor Sarfaraz K. Niazi of the College of Pharmacy and Pharmaceutical Sciences at Washington State University has submitted a Citizen Petition to the ...

Data reviewed by Dr. Helen Sabzevari at last week's Goldman Sachs healthcare conference suggests potential of extended surgical holidays for patients with RRP, a rare respiratory disease GERMANTOWN, ...

As a wave of biologics faces patent expiration, the pharma industry encounters a critical shortage of skilled leaders to navigate the complex biosimilar market, creating a talent war.

The petition requests that the FDA broaden the scientific principles supporting generics and biosimilars to encompass all eligible FDA-approved drugs and biological products. This initiative has the ...