Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2020
Assembly Biosciences announces FDA fast track designation granted to ABI-H2158 for the treatment of chronic hepatitis B virus infection
9 July 2020 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H2158 (2158) for ...
Posted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...
Posted by Michael Wonder on 09 Jul 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma
9 July 2020 - Application based on data comparing Keytruda to standard care (brentuximab vedotin) from pivotal Phase 3 KEYNOTE-204 trial. ...
Posted by Michael Wonder on 09 Jul 2020
Mylan and Fujifilm Kyowa Kirin Biologics announce U.S. FDA approval of Hulio (adalimumab-fkjp)
9 July 2020 - Mylan and Fujifilm Kyowa Kirin Biologics today announced that the U.S. FDA has approved Hulio (adalimumab-fkjp), ...
Posted by Michael Wonder on 09 Jul 2020
Brilinta granted FDA priority review for the reduction of subsequent stroke in patients who had an acute ischaemic stroke or transient ischaemic attack
9 July 2020 - Brilinta in combination with aspirin could be the first FDA approved dual anti-platelet therapy to reduce the ...
Posted 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. ...