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

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

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 ...

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 ...

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.

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The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed ...

Novartis will acquire Avidity Biosciences in a newly announced definitive merger agreement. The news follows the separation ...

PE: What policy incentives are created by FDA's ANDA Prioritization Pilot? Botha: Right now, we’re seeing multiple efforts ...

GSK is set to acquire the exclusive rights for Syndivia’s preclinical antibody-drug conjugate (ADC), which is currently in ...

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