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

This approval is a crucial step in HS Hyosung Advanced Materials’ strategy to address climate change through scientifically validated targets. This SBTi certification known for its stringent ...

An effort by the Trump administration to pull down Food and Drug Administration website pages focused on diversity, equity, and inclusion has ensnared many pages focused on ensuring that clinical ...

The FDA also gave its nod to Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), the first new class of antischizophrenia drug to be approved in decades. Roughly one-third of last ...

The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression ...

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD ...

J&J announced the FDA’s supplemental approval Tuesday. Previously, Spravato was approved as an add-on therapy for treatment-resistant depression, in conjunction with an oral antidepressant.

On Tuesday, the Food and Drug Administration (FDA) approved Johnson & Johnson’s nasal spray, Spravato (esketamine), to treat major depressive disorder. Oral antidepressants are the most common ...

Johnson & Johnson's Spravato has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants, the FDA announced Tuesday.

Spravato was already available in the market before today's FDA approval and has already proven to be a financial success for J&J but only as an adjunct therapy to oral antidepressants for TRD.

Atara says it remains eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the EBVALLO BLA, as well as significant double-digit tiered royalties as a ...

The FDA has approved Johnson & Johnson’s (J&J) Spravato (esketamine) CIII nasal spray, marking the first monotherapy to be approved for adults with treatment-resistant depression (TRD). According to ...