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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. Read More
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 study of amyotrophic lateral sclerosis (ALS). Read More
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. Read More
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 adverse event (SAE) that could have been life-threatening. Read More
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 meeting in Chicago, June 19-23. Read More
The FDA claims it prevented a total of 317 drug shortages in 2021 — marking the highest number of potential shortages avoided since the agency began reporting them to Congress in 2012. Read More
Bipartisan legislation on lowering insulin costs is headed to a vote on the Senate floor “very soon,” according to U.S. Senate Majority Leader Chuck Schumer. Read More
In a draft guidance issued today, the FDA lists three reasons the agency might rescind a Breakthrough Therapy designation (BTD), citing a change in the data supporting the designation or the circumstances surrounding the drug’s development. Read More