Atara Biotherapeutics (NASDAQ:ATRA) has announced plans to cut around 50% of its workforce, just a little over a week after it said the FDA had declined to approve its immunotherapy Ebvallo. The biotech company said it expects to recognize approximately $7.

Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review of the applications is expected to by completed in Q4 2025, according to a statement.

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1,

Michael Benkowitz, President and COO of United Therapeutics Corp (NASDAQ:UTHR), recently executed a series of stock transactions as reported in a recent SEC filing. On January 27, Benkowitz sold shares amounting to approximately $3.

A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic competition to battles over getting more drugs to market.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...

Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...

Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the national launch of the company’s FDA-approved, NGS-based ...

(RTTNews) - AstraZeneca (AZN), on Friday, announced that the FDA has approved CALQUENCE in ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...

Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (SNDX) have received FDA approval for their drug Niktimvo in 9 mg and 22 mg vial sizes. Niktimvo was approved in August 2024 for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg,

Taysha Gene Therapies offers hope for Rett syndrome with innovative treatment, strong trial results, and promising regulatory path. See more on TSHA stock here.

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $256.56 million and impressive gross profit margins of 93.62%, disclosed through a social media post that it has submitted a new drug application to the U.