FDA News

DUBLIN--(BUSINESS WIRE)--The "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" training has been added to ResearchAndMarkets.com's offering. Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good g...

PRINCETON, N.J.--(BUSINESS WIRE)--U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications...

BOSTON & STAFFORDSHIRE, England--(BUSINESS WIRE)--Following the FDA’s recent announcement expanding flexibility in preclinical submission evidence, Instem is reaffirming its role as the industry’s trusted provider of an end-to-end preclinical platform - empowering life sciences organizations with the tools, insight, and scientific depth needed to thrive in an increasingly dynamic regulatory environment. While many view this shift by the FDA as a new direction, Instem sees it as a natural progre...

GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet to present partner data showing how needle-free can be expected to enhance vaccine immune response in difficult-to-treat cancer patients....

SAN ANTONIO--(BUSINESS WIRE)--bioAffinity Technologies is implementing efficiency measures for CyPath Lung that streamline lab processing and data acquisition and reduce lab costs....

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that it has received Breakthrough Device designation from the U.S. Food and Drug Administration (“FDA”) for its vCLASTM Cryoablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (“VT”) in patients with ischemic or non...

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the appointment of Chip Clark to the company’s board of directors. “Chip possesses a wealth of experience leading innovative biotechnology companies,” stated Richard H. Douglas, Ph.D., Chairman of the Board at Aldeyra Therapeutics. “We look forward to le...

PHILADELPHIA--(BUSINESS WIRE)--GSK’s 5-in-1 meningococcal vaccine PENMENVY receives positive recommendation from US Advisory Committee on Immunization Practices...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). This includes ABRYSVO® (Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug...

NASHVILLE, Tenn.--(BUSINESS WIRE)--PursueCare, a leading provider of virtual addiction treatment and specialized pharmacy services, is proud to announce its participation in the Rx and Illicit Drug Summit, taking place April 21–24, 2025, in Nashville, Tenn. Attendees can connect with the PursueCare team at Booth #422 to explore innovative digital health solutions for substance use disorder (SUD) and opioid use disorder (OUD). PursueCare’s RESET® and RESET-O® are the only FDA-authorized digital...