The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as ...

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

US pharma firms face higher drug costs, delayed launches, and compliance risks from proposed sectoral tariffs, prompting ...