Nasdaq4d
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 ...
Nasdaq3d
Firefly Neuroscience Advances Brain Age Assessment Research with FDA-Cleared BNA™ Technology
Firefly (NASDAQ: AIFF) is an Artificial Intelligence ... for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology ...
Nasdaq4d
SeaStar Medical Receives FDA Approval for SCD-ADULT Study Funded by $3.6 Million NIH Grant
FDA approves SeaStar Medical's SCD-ADULT study ... check out Quiver Quantitative's insider trading dashboard. (Nasdaq: ICU), a commercial-stage medical device company developing proprietary ...
Nasdaq11d
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 ...
Nasdaq3d
22nd Century Group's VLN Reduced Nicotine Cigarettes Gain FDA Authorization Amid New Smoking Reduction Policies
22nd Century Group, Inc. has been highlighted in a Washington Post article discussing new FDA policies aimed at reducing the health risks associated with smoking, particularly through the ...
Nasdaq11d
Apyx Medical Submits FDA 510(k) Premarket Notification for Innovative AYON Body Contouring System
Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the ... premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System.
Nasdaq7d
Pharma Stock Roundup: FDA Updates for JNJ, GSK, PFE, NVO's Expanded Deal
The FDA granted priority review designation to J&J’s biologics license application (BLA) seeking approval of nipocalimab for antibody-positive patients with gMG, a rare, autoantibody-driven disease.
Nasdaq7d
FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab
Johnson & Johnson JNJ announced that the FDA has accepted its regulatory filing seeking the FDA’s approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in ...
Nasdaq7d
Revvity Reports FDA Clearance For EUROIMMUN's Automated Chemiluminescence-based Immunoassay Test
(RTTNews) - Revvity (RVTY) received 510(k) clearance from FDA for EUROIMMUN's automated ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Nasdaq4d
FDA Accepts Eisai And Biogen's BLA For Subcutaneous LEQEMBI For Early Alzheimer's Disease
The US FDA accepted Eisai's Supplemental Biologics ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...
Nasdaq7d
FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib
Exelixis, Inc. EXEL announced that the FDA has notified it about an update to its supplemental new drug application (sNDA) for cabozantinib. The sNDA is seeking approval for cabozantinib for the ...
Nasdaq10d
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 ...