Nasdaq28d
Biotech Stocks Facing FDA Decision In January 2025
In 2024, the FDA approved 50 novel drugs ... 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
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 ...
Nasdaq14d
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 ...
Nasdaq27d
ANI Pharmaceuticals Launches Prucalopride Tablets Following FDA Approval
(Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride ...
Nasdaq19d
FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab
The FDA filing is supported by data from the phase ... We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that ...
Nasdaq21d
Rezolute Gains FDA Breakthrough Designation for Ersodetug
Discover outperforming stocks and invest smarter with Top Smart ... Rezolute, Inc. announced that the FDA has granted Breakthrough Therapy Designation to its drug, ersodetug, for treating ...
Nasdaq22d
Rezolute receives BTD from FDA for ersodetug in treatment of hypoglycemia
Rezolute (RZLT) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to ersodetug, RZ358, for the treatment of hypoglycemia due to ...
Nasdaq16d
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 ...
Nasdaq22d
Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
Nasdaq12d
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 ...
Nasdaq7d
Elicio Therapeutics Receives Supportive FDA Feedback for ELI-002 Phase 3 Study Design, Gains Momentum for Cancer Immunotherapy Development
Received supportive FDA feedback on key elements of the potential ... Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company ...
Nasdaq29d
Inogen Stock Rises as FDA Clears SIMEOX 200 Airway Clearance Device
The FDA clearance of the SIMEOX 200 positions Inogen ... You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. MASI’s earnings surpassed estimates in each of ...