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...
Forge Biologics, a leading manufacturer of genetic medicines, today announced that its manufacturing facility has successfully completed the audits necessa...
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...
The Centers for Disease Control and Prevention today reported 26.7 percent of people with autism spectrum disorder have "profound autism". It is the first ...
"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...
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...
Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED said, “The NMPA acceptance of our NDA for fruquintinib is a positive step towa...
“This submission is an important milestone for the ProMIS team as we advance our lead compound, PMN310, toward the clinic. We are excited to continue...
The decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implem...
Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), announced that the U.S. Food and Drug Admini...
The FDA clearance opens the door to the world's largest medical device market. With the cost effectiveness and demonstrated ability of our cardiac monitori...
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