Earlier this year, the FDA approved 2 new indications for Aquaflor. According to Merck, the supplemental approval increased ...

The recent FDA approval of Kebilidi, a groundbreaking gene therapy for AADC deficiency, is a significant milestone for the company. It is the first gene therapy directly administered to the brain and ...

It’s hard to watch the news or scroll through social media without encountering stories about weight loss drugs like ...

Critical wins that underpinned the significant milestone included the following: first, the FDA confirmed that the amended ...

The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene ...

Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...

Some pet owners want a recall of a new arthritis drug for cats after their animals died, some in horrific ways, just days ...

NYHA Class IV Approval: In August 2024, scPharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted approval for FUROSCIX, expanding the indication to include New York Heart ...

Johnson & Johnson shows strong progress in oncology with Darzalex sales and regulatory filings, leading to a 'Buy' rating ...

Learn more about how an anesthetic traditionally used for surgical procedures may help depression and what to expect during ...

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

The Food and Drug Administration certainly gives little margarine for error after recalling nearly 80,000 pounds of Costco ...