Nasdaq9d
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 ...
Nasdaq9d
FDA Approves Qelbree Label For ADHD And Lactation
Qelbree is now the first ADHD treatment to meet the FDA's post-marketing requirement ... the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Nasdaq8d
CLPT Stock Gains on FDA Clearance for Navigation Software Version 3.0
This signifies the first-ever FDA marketing authorization of a device ... You can see the complete list of today’s Zacks #1 Rank stocks here. VCYT’s earnings surpassed estimates in each ...
Nasdaq9d
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 ...
Nasdaq7d
FDA Clears Allogene's IND for CAR T Therapy in Autoimmune Diseases
Allogene Therapeutics, Inc. ALLO announced that the FDA has cleared its investigational ... the average surprise being 172.72%. 7 Best Stocks for the Next 30 Days Just released: Experts distill ...
Nasdaq12d
Pharma Stock Roundup: JNJ's Q4 Earnings, FDA Nod to AZN, Daiichi Drug
FDA Approves AZN & Daiichi’s Dato-DXd for ... Here’s how the eight major stocks performed in the previous five trading sessions. Image Source: Zacks Investment Research In the last five ...
Nasdaq8d
FDA Clearance For Allogene's ALLO-329, Targeting Autoimmune Diseases
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 ...
Nasdaq9d
Cartesian Therapeutics Receives FDA Agreement on Phase 3 Trial Design for Descartes-08 in Myasthenia Gravis
Cartesian Therapeutics, Inc. announced that it received FDA agreement on the design of ... Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company ...
Nasdaq9d
FDA To Review Alvotech/Teva's BLA For AVT05, The 1st Biosimilar To Golimumab
This marks the first U.S. BLA filing for a biosimilar to Simponi/Simponi Aria, with the FDA review expected to ... do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s ...
Nasdaq9d
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 ...
Nasdaq13d
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA ...
Nasdaq9d
Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
The SPA agreement indicates that the FDA has determined that the proposed ... of the author and do not necessarily reflect those of Nasdaq, Inc. Sign up for our newsletter to get the latest ...