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...
Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for u...
Nefecon NDA is currently under Priority Review in China and expected to receive approval in 2H 2023- Everest Medicines (HKEX 1952.HK, "...
Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today that the ...
The Patent No. US 11,602,282 B2 describes how the signals recorded from Nox standard respiratory effort bands (RIP) can be used to derive information on in...
Histogen Inc. (HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-casp...
ncyte (Nasdaq:INCY) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fi...
IND for phase 2b/3 trial submitted to the FDA Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering novel approac...
As part of the transaction, certain operational obligations of the parties related to GS-1811, an anti-CCR8 antibody, set forth in the license agreement ha...
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