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.
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,
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,
MindMed's LSD Anxiety Drug: Revisiting, Rethinking, But Maintaining My 'Hold' Call
Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.
FDA approves Qelbree label update for ADHD treatment
ROCKVILLE, Md. - Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company specializing in CNS diseases with an impressive 89% gross profit margin, has announced the FDA approval of a label update for its ADHD treatment,
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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 ...
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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 ...
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.
FDA accepts Replimune's advanced melanoma therapy BLA
Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has been accepted by the U.
Scholar Rock: More Than Just An SMA Biotech With Q2 2025 Obesity Treatment Data
Scholar Rock submitted its BLA of apitegromab for the treatment of patients with Spinal Muscular Atrophy with a request for Priority Review to be given. Explore more details here.
What's Wrong With Iovance Biotherapeutics Stock?
It was about a year ago that shares of Iovance Biotherapeutics (NASDAQ: IOVA) began to take off. Could this be a great buying opportunity for investors, or is the healthcare stock in danger of falling even lower this year?