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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
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
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
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
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
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 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 ...
Posted by Michael Wonder on 21 Dec 2020
U.S. FDA approves supplemental new drug application for Takeda’s Iclusig (ponatinib) for adult patients with resistant or intolerant chronic phase CML
19 December 2020 - Approval based on data from the Phase 2 OPTIC trial, which evaluated response-based Iclusig dosing regimens in ...
Posted by Michael Wonder on 20 Dec 2020
Hikma launches generic Advair Diskus following FDA approval
17 December 2020 - Hikma Pharmaceuticals announces it has received FDA approval for and launched its generic version of GlaxoSmithKline’s ...
Posted by Michael Wonder on 19 Dec 2020
Karyopharm announces FDA approval of Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior therapy
18 December 2020 - Oral Xpovio now available as a treatment option for patients with multiple myeloma as early as first ...
Posted by Michael Wonder on 19 Dec 2020
FDA takes additional action in fight against COVID-19 by issuing emergency use authorisation for second COVID-19 vaccine
18 December 2020 - Action follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input ...