A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...

The FDA is set to consider approval of an alternative to opioids developed by Vertex Pharmaceuticals, The Washington Post reported Jan. 13.

FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.

As part of the regulatory action, memantine/donepezil extended-release capsules have been granted a 180-day exclusivity in ...

The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.

The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies ...

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

Vertex secures FDA approval for ALYFTREK and expands TRIKAFTA use, advances diabetes and kidney disease therapies, and ...

After a delayed approval, treosulfan’s manufacturer is hopeful the alkylating agent will become the new gold standard in the United States.