Nasdaq12d
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
VRTX Gets FDA Nod for Non-Opioid Pain Drug Journavx, Shares Up
Vertex Pharmaceuticals Incorporated VRTX announced that the FDA has approved its oral ... From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more ...
Nasdaq13d
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 ...
Nasdaq25d
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 ...
Nasdaq7d
HCW Biologics Inc. Receives FDA Clearance for IND Application to Initiate Phase 1 Clinical Trial of HCW9302 for Alopecia Areata
HCW Biologics Inc. has announced the FDA's approval of its Investigational ... HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical ...
Nasdaq14d
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 ...
Nasdaq12d
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 ...
Nasdaq26d
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 ...
Nasdaq14d
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 ...
Nasdaq28d
22nd Century Group Supports FDA's Proposed Reduced Nicotine Content Standard Following OMB Review Completion
The FDA spokesperson indicated that the policy could ... 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should ...
Nasdaq14d
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 ...
Nasdaq25d
ImmunityBio Provides Update On FDA Submissions For 2025
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 ...