Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

"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...

April 20, 2023 | Thursday | News
Otsuka and Lundbeck's Statement on FDA Advisory Committee Meeting for REXULTI in Alzheimer's Agitation

Otsuka Pharmaceutical Development & Commercialization, Inc., (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the Joint Meeting of the Psy...

April 18, 2023 | Tuesday | News
Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol

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...

April 18, 2023 | Tuesday | News
HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer

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...

April 18, 2023 | Tuesday | Regulatory
ProMIS Neurosciences Announces Submission of Investigational New Drug (IND) Application for Lead Antibody PMN310

“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...

April 11, 2023 | Tuesday | News
Covis Statement on FDA Decision to Withdraw Approval of Makena®

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...

April 09, 2023 | Sunday | News
Molecular Templates Announces Partial Clinical Hold for Phase 1 Study of MT-0169

Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”),  announced that the U.S. Food and Drug Admini...

April 09, 2023 | Sunday | News
Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

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...

April 07, 2023 | Friday | News
Synapse Biomedical Receives New Approval for Diaphragm Pacing System to Free Patients from Ventilators

Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for u...

April 06, 2023 | Thursday | News
Everest Medicines Announces New Drug Application Acceptance by Singapore HSA

Nefecon NDA is currently under Priority Review in China and expected to receive approval in 2H 2023- Everest Medicines (HKEX 1952.HK, "...

April 06, 2023 | Thursday | News
Perfuse Therapeutics' PER-001 Intravitreal Implant clears FDA IND application for Glaucoma trial

Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today that the ...

April 05, 2023 | Wednesday | News
Nox Medical Secures New Patent for Calculating Respiratory Effort During Sleep Studies

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...

April 05, 2023 | Wednesday | News
Histogen Announces Exclusive Intellectual Property License Agreement with Johns Hopkins University

Histogen Inc. (HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-casp...

April 04, 2023 | Tuesday | News
Incyte's Pemazyre® (pemigatinib) Approved in Japan for Myeloid/Lymphoid Neoplasms (MLNs)

ncyte (Nasdaq:INCY) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fi...

March 28, 2023 | Tuesday | News

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