The US drug regulator has completed a pre-approval inspection at Emcure’s Ahmedabad oncology facility without issuing a Form ...

For a pharmaceutical company, a clean FDA inspection report is crucial for maintaining and expanding its presence in global markets ...

Alexander Malyshev and Sarah Ganley of Carter Ledyard & Milburn LLP discuss a gray area when the 2018 Farm Bill legalized ...

Looming threats to pharmaceuticals and the drug supply chain have brought fresh attention to onshoring. Experts say ...

One-in-six patients treated with the modified virus as part of a clinical trial saw their tumors disappear completely.

The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, ...

Fountain Life operates four flagship longevity centers, including two in Florida, where a new state law effective July 1, ...

“The best outcomes, explains Dr. Modak, “occur when the medication is administered within 3 to 4.5 hours of the onset of ...

Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on ...

Topline results from the CHASE trial expected by end of Q3 2025 -- -- Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on ...

I think the commission and the staff are more encouraged than we have been any time in the past to date.” By Alander Rocha, ...

The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...