Atara to cut 50% of workforce amid FDA woes
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.
FDA accepts Teva, Alvotech BLAs for Simponi biosimilars
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.
United Therapeutics president sells shares worth $3.7 million
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.
Vanda Pharmaceuticals seeks FDA nod for motion sickness drug
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.
D.C.'s Vanda Pharmaceuticals battling FDA on multiple fronts
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.
Nasdaq10d
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
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 ...
Replimune stock soars on FDA priority review for melanoma treatment
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,
Nasdaq12d
J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
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 ...
Nasdaq11d
FDA Approves AstraZeneca's Calquence For Patients With Untreated Mantle Cell Lymphoma
(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 ...
Nasdaq13d
Tempus Announces the National Launch of FDA-Approved xT CDx Test
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 ...
Taysha Gene Therapies Is Showing Promise For Rett Syndrome
Taysha Gene Therapies offers hope for Rett syndrome with innovative treatment, strong trial results, and promising regulatory path. See more on TSHA stock here.
Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch
Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a trial designed to test an over-the-counter version of its erectile dysfunction (ED) drug,