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RSS FeedPosted by Michael Wonder on 05 May 2021
FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer
5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...
Posted by Michael Wonder on 05 May 2021
FDA accepts Amgen's supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
5 May 2021 - Acceptance based on data from Phase 3 ADVANCE trial, demonstrating clinically meaningful improvements through week 32. ...
Posted by Michael Wonder on 05 May 2021
US FDA accepts GC Pharma’s biologics license application for immunoglobulin 'GC5107'
5 May 2021 - A significant milestone towards entering the world's largest plasma product marketplace. ...
Posted by Michael Wonder on 05 May 2021
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib) in IDH1 mutated cholangiocarcinoma
5 May 2021 - Servier Pharmaceuticals today announced that the U.S. FDA has accepted the company's supplemental new drug application for ...
Posted by Michael Wonder on 04 May 2021
Pfizer will file for full FDA approval by end of May
4 May 2021 - Pfizer and BioNTech, the manufacturers of one of the three authorised COVID-19 vaccines in the U.S., plan ...
Posted by Michael Wonder on 04 May 2021
ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV
4 May 2021 - If approved, cabotegravir would be the first, long-acting therapy for HIV PrEP. ...
Posted by Michael Wonder on 04 May 2021
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent
4 May 2021 - Breakthrough designation helps advance treatment options, targeting a significant unmet need in the treatment of critical limb-threatening ischaemia. ...
Posted by Michael Wonder on 04 May 2021
SIGA announces new drug application filing with FDA for intravenous formulation of TPOXX
4 May 2021 - Important for patients who cannot swallow oral capsules. ...
Posted by Michael Wonder on 04 May 2021
Clearside Biomedical announces resubmission of new drug application for Xipere for treatment of macular oedema associated with uveitis
3 May 2021 - Clearside Biomedical announced today the resubmission of its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 03 May 2021
Amphastar Pharmaceuticals receives FDA approval for morphine sulphate injection
3 May 2021 - Amphastar Pharmaceuticals announced that the U.S. FDA approved the Company’s abbreviated new drug application for morphine sulphate ...
Posted by Michael Wonder on 03 May 2021
ImmunoMet Therapeutics granted fast track designation by U.S. FDA for IM156 in idiopathic pulmonary fibrosis
3 May 2021 - ImmunoMet Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead compound ...
Posted by Michael Wonder on 03 May 2021
Intra-Cellular Therapies announces FDA acceptance of Caplyta (lumateperone) sNDAs for the treatment of bipolar depression
3 May 2021 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its supplemental new drug applications ...
Posted by Michael Wonder on 03 May 2021
How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects
3 May 2021 - The term B.C. took on a new meaning — Before COVID — last year when almost ...
Posted by Michael Wonder on 03 May 2021
Hutchmed completes rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
3 May 2021 - First NDA submission by Hutchmed in the U.S.; product launch preparations underway. ...
Posted by Michael Wonder on 03 May 2021
ALS groups to the FDA and drug sponsors: ‘We won’t be played again’
30 April 2021 - Working to improve the fight for therapies for amyotrophic lateral sclerosis (ALS, also known as Lou ...