Blog
RSS FeedPosted by Michael Wonder on 26 Dec 2020
Sumitovant Biopharma announces Urovant Sciences receives U.S. FDA approval of Gemtesa (vibegron) 75 mg tablets for the treatment of patients with overactive bladder
23 December 2020 - Sumitovant Biopharma today announced that Urovant Sciences has received U.S. FDA approval of its new drug application ...
Posted by Michael Wonder on 23 Dec 2020
FDA approves Bracco Diagnostics' ProHance (gadoteridol) Injection, 279.3 mg/mL, for paediatric patients younger than two years
23 December 2020 - Bracco Diagnostics today announced that the U.S. FDA has approved ProHance (gadoteridol 279.3 mg/mL injection) for ...
Posted by Michael Wonder on 23 Dec 2020
Pfizer to supply US with additional 100 million vaccine doses
24 December 2020 - Pfizer says it will supply the US government with an additional 100 million doses of its ...
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
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
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
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 ...
Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
Posted by Michael Wonder on 21 Dec 2020
Sesen Bio submits completed biologics license application to the FDA for Vicineum and has requested priority review
21 December 2020 - BLA supported by strong Phase 3 VISTA trial data and positive analytical comparability data. ...
Posted by Michael Wonder on 21 Dec 2020
Vertex announces FDA approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations
21 December 2020 - More than 600 people with certain rare cystic fibrosis mutations are now eligible for Trikafta, Symdeko or ...