Nasdaq10d
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 ...
Nasdaq8d
Adial Pharmaceuticals Completes Pharmacokinetics Study of AD04, Prepares for FDA End-of-Phase 2 Interaction
We have engaged with the FDA on the results of this PK bridging ... and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive ...
Nasdaq10d
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 ...
Nasdaq9d
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 ...
Nasdaq7d
Axsome Therapeutics Receives FDA Approval for SYMBRAVO, a Novel Acute Treatment for Migraine Pain Relief
The FDA approval of SYMBRAVO for the acute treatment of migraines provides a significant new treatment option for millions of Americans suffering from this debilitating condition. SYMBRAVO ...
Nasdaq10d
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 ...
Nasdaq8d
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 ...
Nasdaq13d
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 ...
Nasdaq9d
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 ...
Nasdaq10d
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 ...
Nasdaq10d
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 ...
Nasdaq10d
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 ...