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RSS FeedPosted by Michael Wonder on 08 May 2018
FDA approves supplemental new drug application for Myrbetriq (mirabegron) for use in combination with solifenacin succinate for the treatment of overactive bladder symptoms
7 May 2018 - Astellas announced today that the U.S. FDA has approved a supplemental new drug application for the ...
Posted by Michael Wonder on 08 May 2018
Salix receives FDA approval for Plenvu, next generation 1 litre bowel cleansing preparation for colonoscopies
7 May 2018 - Salix Pharmaceuticals and its partner Norgine announced today that the U.S. FDA has approved Plenvu (polyethylene glycol ...
Posted by Michael Wonder on 08 May 2018
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in newly diagnosed multiple myeloma
7 May 2018 - First approval for Darzalex in a frontline indication. ...
Posted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 06 May 2018
U.S. FDA approves Portola Pharmaceuticals’ Andexxa, first and only antidote for the reversal of factor Xa inhibitors
3 May 2018 - Breakthrough product is a major advance in the treatment of patients hospitalised with life-threatening bleeding. ...
Posted by Michael Wonder on 06 May 2018
Ferring signs global agreement to commercialise novel gene therapy for bladder cancer patients
3 May 2018 - The US FDA has granted fast track and breakthrough therapy designations to rAd-IFN/Syn3. ...
Posted by Michael Wonder on 05 May 2018
FDA grants PaxVax fast track designation for its Chikungunya vaccine
4 May 2018 - There are no licensed vaccines for chikungunya prevention and no specific treatments. ...
Posted by Michael Wonder on 05 May 2018
Novartis matches Gilead on price in new CAR-T use
3 May 2018 - Novartis’ CAR-T therapy Kymriah will be available in the US to adults with relapsed large B-cell ...
Posted by Michael Wonder on 05 May 2018
Gottlieb pushes back against criticism of ‘breakthrough’ designation
4 May 2018 - FDA Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that ...
Posted by Michael Wonder on 05 May 2018
FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
4 May 2018 - The U.S. FDA approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 03 May 2018
Coherus Biosciences re-submits biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
3 May 2018 - Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, ...
Posted by Michael Wonder on 03 May 2018
FDA updates Trintellix (vortioxetine) label to include data showing improvement in processing speed, an important aspect of cognitive function in acute major depressive disorder
2 May 2018 - Trintellix (vortioxetine) is the first FDA-approved treatment for MDD to have data in the U.S. Prescribing Information ...
Posted by Michael Wonder on 03 May 2018
Migraine drug delay would compound Teva's troubles
2 May 2018 - Teva Pharmaceutical Industries is counting on its new migraine treatment to haul it out of the ...
Posted by Michael Wonder on 03 May 2018
Cellectar receives rare paediatric disease designation for CLR 131 to treat neuroblastoma
2 May 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to the ...