Blog
RSS FeedPosted by Michael Wonder on 29 Dec 2020
FDA approves first generic of drug used to treat severe hypoglycaemia
28 December 2020 - Today, the U.S. FDA approved the first generic of glucagon for injection USP, 1 mg/vial packaged in ...
Posted by Michael Wonder on 28 Dec 2020
Chi-Med initiates rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
28 December 2020 - Company plans to complete rolling submission in the first half of 2021. ...
Posted by Michael Wonder on 28 Dec 2020
Imbruvica (ibrutinib) U.S. Prescribing Information updated to include long-term data for Waldenström's macroglobulinemia
23 December 2020 - Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated ...
Posted by Michael Wonder on 27 Dec 2020
FDA acceptance for the filing of new drug application
23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA ...
Posted by Michael Wonder on 27 Dec 2020
Pandemic delays FDA decision on Biocon's bevacizumab application
27 December 2020 - For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its ...
Posted by Michael Wonder on 26 Dec 2020
Novadip Biosciences receives rare paediatric disease priority review and orphan disease designation
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
Posted 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 ...