The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
AASCP is hosting an FDA Panel and many distinguished physicians this weekend at their annual Scientific Congress. All physicians practicing stem cell treatments should not miss this event on Nov. 1-3, 2019.
LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market.
Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets
Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).
Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020
A new partnership between CEFALY Technology and QB Medical puts wearable medical devices in the hands of health care providers and grants active military immediate relief from migraine headaches
Former U.S. Food and Drug Administration (FDA) commissioner David Kessler drew attention last week when he said he thought Juul and other popular vaping manufacturers would be forced to leave the market under proposed FDA rules.
All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").
The U.S. Food and Drug Administration (FDA) has awarded AnaBios an exclusive Indefinite Delivery Indefinite Quantity (IDIQ) contract to employ adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function.
Innovative ventilation system that can be used across health care settings for full range of patients
Camurus AB (NASDAQ STO: CAMX) announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request (through Citizen Petition) to revoke orphan drug designation of Sublocade™.
UVision360 Inc., creators of the patented LUMINELLE® DTx Hysteroscopy System, announced the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE® Dx 360˚ Rotatable Disposable Sheath (Diagnostic).
AI Medical Service Inc., one of the world's first real-time endoscopic artificial intelligence (AI) developers, today announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its AI programs that analyze endoscopy images for potential diagnosis of gastric cancer.
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IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow.