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RSS FeedPosted by Michael Wonder on 23 Dec 2020
The European Commission approves Zogenix’s Fintempa (fenfluramine) oral solution for the treatment of seizures in Dravet syndrome
21 December 2020 - First EU market launch planned for Germany in Q1 2021. ...
Posted by Michael Wonder on 23 Dec 2020
Occlutech’s atrial flow regulator receives U.S. FDA breakthrough device designation
18 December 2020 - Occlutech announced today that the US FDA has granted the company a breakthrough device designation for its ...
Posted by Michael Wonder on 23 Dec 2020
Health Canada approves ALK's Ragwitek sublingual allergy immunotherapy tablets for paediatric patients with ragweed allergy
22 December 2020 - With the indication expanded to paediatric patients, ALK Canada now provides adults and children a SLIT tablet ...
Posted by Michael Wonder on 23 Dec 2020
Janssen announces Health Canada approval of Darzalex combination regimen for newly diagnosed, transplant eligible patients with multiple myeloma
22 December 2020 - Data show Darzalex in combination with bortezomib, thalidomide and dexamethasone before and after autologous stem cell transplant ...
Posted by Michael Wonder on 23 Dec 2020
TricValve transcatheter bicaval valves system granted designation as breakthrough device by the U.S. FDA
22 December 2020 - P+F Products + Features has been granted designation as a breakthrough bevice for the company's lead product, ...
Posted by Michael Wonder on 22 Dec 2020
Amgen submits sotorasib marketing authorisation application to the European Medicines Agency
22 December 2020 - Application is for patients with previously treated non-small cell lung cancer with the KRAS G12C mutation. ...
Posted by Michael Wonder on 22 Dec 2020
ViiV Healthcare announces the marketing authorisation of the first complete long-acting injectable HIV treatment in Europe
21 December 2020 - Marketing authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves Kineret (anakinra) for the treatment of deficiency of IL-1 receptor antagonist
22 December 2020 - DIRA is an ultra-rare, auto-inflammatory disease that typically presents in infancy and is characterised by life-threatening and ...
Posted by Michael Wonder on 22 Dec 2020
Ocular Therapeutix announces submission to the FDA of a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular itching associated with allergic conjunctivitis
22 December 2020 - PDUFA target action date anticipated for October 2021. ...
Posted by Michael Wonder on 22 Dec 2020
EMA organises a second public meeting about the new COVID-19 vaccines
22 December 2020 - EMA will organise a second public meeting on 8 January 2021 to inform European citizens about ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves prosthetic implant for above the knee amputations
18 December 2020 - The U.S. FDA today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves paediatric indication for Xeomin (incobotulintoxinA) for the treatment of chronic sialorrhoea
21 December 2020 - Xeomin is the first and only neuromodulator approved in the U.S. to treat paediatric patients with chronic ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves treatment for Ebola virus
21 December 2020 - The U.S. FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) ...
Posted by Michael Wonder on 22 Dec 2020
Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma
21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 21 Dec 2020
The FDA grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma
15 December 2020 - IO Biotech today announced that the U.S. FDA has granted breakthrough therapy designation for a combination ...