PE: How long will it take for the market to be impacted by FDA's ANDA Prioritization Pilot? Botha: It’s a relative window. It ...

Raj Indupuri, CEO, eClinical Solutions,pharma’s biggest AI adoption hurdles lie in scaling beyond pilots, ensuring data ...

Along with the company’s investment plans in Puerto Rico, Lilly also announced plans to build a $5 billon manufacturing plant ...

Head of FDA’s drug center George Tidmarsh is the latest member to see his name in headlines. On Friday, October 31, FDA ...

Pfizer's lawsuits target Metsera, its directors, and Novo Nordisk for breach of contract and antitrust violations, focusing on Novo Nordisk's acquisition proposal. The first lawsuit claims Novo ...

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.

In today’s Pharmaceutical Executive Daily, we cover Eli Lilly’s plan to submit its oral GLP-1 candidate for FDA priority review, the departure of senior FDA official George Tidmarsh, and growing ...

Advanced CGTs are expanding to larger patient populations, requiring strategic distribution approaches centered on patient needs. Effective channel strategies, broadening access, and reducing ...

HHS Secretary Kennedy stated there is insufficient evidence to link Tylenol to autism, conflicting with the Texas lawsuit.

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed ...

In today’s Pharmaceutical Executive Daily, we cover the resignation of Organon CEO Kevin Ali following an internal ...

Thermo Fisher Scientific is set to acquire Clario Holdings after entering a $8.8 billion definitive agreement, which includes ...