Lawsuits are questioning whether FDA-approved spinal cord stimulators have changed so much over time that they need new ...

Within weeks of submitting its promising daraxonrasib to the Food and Drug Administration (FDA), Revolution Medicines (RVMD +2.65%) won full approval fr ...

The drug, called Rasonque, is a once-daily pill for people with pancreatic cancer who've received prior treatment, or can't get combination therapy.

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). The ...

Getting prescription drugs to market faster is a major priority for the Food and Drug Administration, its commissioner said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum in ...

The U.S. FDA has approved Revolution Medicines’ groundbreaking pancreatic cancer drug after it was shown to double the ...

Femasys has received FDA approval to use a modular premarket approval submission process for FemBloc, giving the company a defined regulatory framework as its pivotal U. S.

GRAIL, Inc. could have a massive catalyst ahead in 2026. FDA approval would open up huge commercial potential for the Galleri test. Medicare coverage and broad coverage by commercial health insurers ...

Drug manufacturing process models represent a "growing area" of scientific development and are increasingly being utilized in ...

The decision caps a seven-month review that included a rare refusal to consider the shot at all.

The SAFE Drugs Act would provide regulators with better tools to identify potential safety concerns, the Alliance for Safe ...