GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals are ahead.

CMS often withholds coverage for reimbursement, disrupting the natural flow of the market and hindering access to proven ...

Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower drug costs. Could it work?

The test, developed in part by Johns Hopkins researchers, will dramatically increase access to early detection and treatment ...

Numerous other morcellator devices were approved through 2011, with each new application citing earlier models for approval. According to WSJ, the FDA used this process to review 99 percent of ...

For example, relevant to clinical decision support, here are a few of the existing classifications into which FDA could shoehorn new standalone software: A calculator/data processing intended to store ...

In a letter to 93 manufacturers, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, wrote that the agency was acting to reduce the number of underdoses ...

The FDA’s regulatory activity does not end with the drug approval process but includes ongoing vigilance to assess problems that were initially missed in the clinical trials phase.

The bottom line Every year, the FDA approves novel drugs, biosimilars, and first generics. Compared to 2024, novel drug and biosimilar approval numbers are slightly behind in the first half of 2025.