Just ahead of its user fee decision date, Spero Therapeutics was slapped with a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for tebipenem HBr…

The FDA should be allowed to reform the citizen petition process and change how complex generic drugs are approved, the Brookings Institution and the University of Southern California (USC) propose…

For circumstances when drugmakers feel labeling alone isn’t enough to ensure safe selection and use, the FDA is proposing a rule that would expand the pool of nonprescription drugs with…

The FDA has released its Spring 2022 regulatory agenda, pushing back the timing of several previously announced proposed and final rules, and signaling its intention to issue a proposed rule…

Gilead Sciences has reached a $33 million settlement with a Florida clinic accused of fraudulently applying to the company’s patient assistance program via homeless people and those in low-wage jobs…

The FDA has expanded the scope of its 2013 drug manufacturing guidance on penicillin cross-contamination to cover compounds containing a non-penicillin beta-lactam ring, a chemical structure essential for antibacterial activity.…

Sarepta Therapeutics has been hit with an FDA clinical hold on its trial of SRP-5051 (vesleteplirsen) for the treatment of Duchenne muscular dystrophy after a trial participant experienced a serious…

Under a new five-year action plan for accelerating the development of treatments for rare neurodegenerative diseases, the FDA will focus on incorporating new technologies and innovative trial approaches beginning with…

The European Medicines Agency (EMA)’s human medicines committee endorsed nine new drugs during its June meeting, including Valneva’s adjuvanted COVID-19 vaccine for use in people age 18 to 50 years.…

A serious backlog of FDA inspections is causing problems for sponsors of biosimilars who are being especially affected by the delays, according to presenters at the Drug Information Association annual…