The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...

The FDA has approved a new treatment for patients with a common form of breast cancer that has spread to other parts of the body or cannot be surgically removed.

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

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...

The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to ...

The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.

THE Food and Drug Administration (FDA) said Friday that it is set to release a new administrative order that would reduce the timeline of drug registration, especially among imported drugs that have ...

With $10 million in new funding, Teal Health co-founder Kara Egan shares how her health care startup intends to reach its first patients.

Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...

The process of getting screened for cervical cancer is quite intimidating. It’s the once-a-year, sometimes life-changing ...

Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter.