The FDA recently granted EXG-34217 Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) Designation.

Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...

The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog, to improve glycemic control in patients with diabetes mellitus.

The cuts hit the FDA’s medical device center particularly hard, impacting product reviewers and researchers of AI-enabled ...

The quick answer is, it's complicated. Number one, quality. Number three, delay of the product. because it's no longer ...

Harmony Biosciences is facing more of a nightmare than sweet dreams on the road to securing a new use for its excessive ...

The U.S. Food and Drug Administration (FDA) has accepted for filing PTC Therapeutics’ New Drug Application (NDA) for ...

Some doctors say drugs that improve muscle mass could benefit older or infirm people at greater risk of falls and fractures.

Shares of Moderna, along with other vaccine makers, dropped further this year as lawmakers advanced U.S. President Donald ...

According to Statifacts, the global clinical trials market size is calculated at USD 126.30 billion in 2025 and is expected to reach around USD 186.09 billion by 2034, growing at a CAGR of 4.4% from ...

As the ASA noted, the U.S. Food and Drug Administration (FDA) has never approved ketamine for any use other than anesthesia. Still, there's been a recent surge in "off-label" use of the infused or ...

Fortunately, we are making some progress as organizations such as the Partnership for Advancing Clinical Trials (PACT) ...