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RSS FeedPosted by Michael Wonder on 09 Jul 2020
U.S. FDA approves Qwo (collagenase clostridium histolyticum-aaes), the first injectable treatment for cellulite
6 July 2020 - Endo International today announced that it received U.S. FDA approval of Qwo (collagenase clostridium histolyticum-aaes) for the ...
Posted by Michael Wonder on 09 Jul 2020
Sarclisa (isatuximab for injection) now available in Canada for patients with relapsed and refractory multiple myeloma
8 July 2020 - First and only anti-CD38 antibody in combination with pomalidomide and dexamethasone to be approved in Canada. ...
Posted by Michael Wonder on 09 Jul 2020
Astex Pharmaceuticals, Taiho Oncology and Otsuka Pharmaceutical announce Health Canada approval of Inqovi (decitabine and cedazuridine) tablets, oral hypomethylating agent therapy for intermediate and high-risk MDS and C
7 July 2020 - Inqovi is the first orally administered hypomethylating agent approved by the FDA and Health Canada. ...
Posted by Michael Wonder on 09 Jul 2020
CorMedix reports submission of Defencath new drug application
8 July 2020 - CorMedix today announced that all of the modules for the Defencath new drug application have been submitted ...
Posted by Michael Wonder on 08 Jul 2020
House proposes $3.2 billion for FDA in FY 2021
7 July 2020 - On Monday, the US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug ...
Posted by Michael Wonder on 08 Jul 2020
A flawed COVID-19 study gets the White House’s attention — and the FDA may pay the price
8 July 2020 - Studies in thousands of people on multiple continents now show the malaria drug hydroxychloroquine does not ...
Posted by Michael Wonder on 08 Jul 2020
Concert Pharmaceuticals receives FDA breakthrough therapy designation for CTP-543 for the treatment of alopecia areata
8 July 2020 - Designation based on Phase 2 data demonstrating significant hair regrowth in patients with alopecia areata. ...
Posted by Michael Wonder on 08 Jul 2020
Biogen completes submission of biologics license application to FDA for aducanumab as a treatment for Alzheimer’s disease
8 July 2020 - If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of ...
Posted by Michael Wonder on 08 Jul 2020
Merck and Eisai receive complete response letter for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination as first-line treatment for unresectable hepatocellular carcinoma
8 July 2020 - Merck and Eisai today announced that the U.S. FDA has issued a complete response letter regarding Merck’s ...
Posted by Michael Wonder on 08 Jul 2020
Lynparza approved in the EU for BRCA mutated metastatic pancreatic cancer
8 July 2020 - Only PARP inhibitor approved in this disease. ...
Posted by Michael Wonder on 07 Jul 2020
U.S. commits $2 billion for COVID-19 vaccine, drug supplies
7 July 2020 - Novavax, Regeneron are awarded government funding. ...
Posted by Michael Wonder on 07 Jul 2020
Senhwa Biosciences's silmitasertib receives rare paediatric disease designation from U.S. FDA for treatment of recurrent sonic hedgehog medulloblastoma
7 July 2020 - Senhwa Biosciences today announced that the U.S. FDA granted rare paediatric disease designation for its drug silmitasertib, ...
Posted by Michael Wonder on 07 Jul 2020
FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes
7 July 2020 - Today, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (Inqovi, Astex ...
Posted by Michael Wonder on 07 Jul 2020
Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU
7 July 2020 - Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective ...
Posted by Michael Wonder on 06 Jul 2020
The development of COVID-19 vaccines: safeguards needed
6 July 2020 - A safe and effective vaccine against coronavirus disease 2019 (COVID-19) is the best way to control and ...