Nasdaq2d
Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment
Invivyd has continued to provide timely updates to the FDA since its initial submission ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
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.
Nasdaq3d
Alvotech: FDA To Review BLA For AVT05 - Quick Facts
The FDA review process is anticipated to be completed ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...
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.
Nasdaq2d
Cartesian Therapeutics Secures FDA SPA Agreement For Phase 3 AURORA Trial
Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for MG and other ... reflect those of Nasdaq, Inc. Founded in the late 1990s ...
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
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 ...
Nasdaq13d
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 ...
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,
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,
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.