The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...

Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESAIY) announced the rolling submission of a marketing application to receive an FDA label expansion for a subcutaneous autoinjector that delivers their Alzheimer ...

The road to FDA clearance for medical devices may change radically in the next year. Last summer, initial discussion began around implementing a pre-certification program for medical device companies, ...

Transplant centers representing about 9% of German transplant volumes and about 2% of U.S. transplant volumes have signed on to use GraftAssure kitted research test in early launch phase FDA ...

HOUSTON, TX, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today ...

Cloudbreak Pharma, Inc. ( ($HK:2592) ) has shared an update. Cloudbreak Pharma Inc. announced that its subsidiary, ADS Therapeutics LLC, has ...

Similar to building a solid house that requires detailed preplanning, an FDA submission should ensure that all product teams be on the same page from day one of concept, according to Matthias Kaeser, ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the ...

Initiating coverage of Insight Molecular Diagnostics Inc. with a Hold rating due to upcoming catalysts and pending FDA submission for GraftAssureDx kidney transplant assay. IMDX's decentralized ...