The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine's NanoVy-HA technology in partnership with Promimic AB. NanoVy-HA is a process in which...
Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery and breakthrough diagnostics through ultrasensitive biomarker detection, today...
Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotid...
-Virios’ IMC-1 Phase 3 Proposed Program is Considered Acceptable based on Initial FDA Feedback Pending Review of the Final Chronic Toxicology Program...
Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its Mini...
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive dise...
"Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of prepara...
What You Need to Know: Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of ...
"Today's approval is an important advance in cell therapy treatment in patients with blood cancers," said Peter Marks, M.D., Ph.D., director of the FDA's C...
Otsuka Pharmaceutical Development & Commercialization, Inc., (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the Joint Meeting of the Psy...
As disclosed in September 2022, Avenue received meeting minutes from the FDA regarding a Type A meeting conducted on August 9, 2022, for IV Tramadol. At th...
The FDA has also recently granted an orphan drug designation (ODD) to GIVI-MPC. Current treatments for DMD have limited therapeutic potential as unfortunat...
Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the init...
"We remain confident in mirikizumab's pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis," said Patrik Jonsson, Lilly e...
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