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RSS FeedPosted by Michael Wonder on 26 Dec 2021
Coherus announces U.S. FDA approval of Yusimry (adalimumab-aqvh)
20 December 2021 - Approved for all eligible indications of the reference biological product, Humira (adalimumab). ...
Posted by Michael Wonder on 26 Dec 2021
Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis related arthritis and psoriatic arthritis
22 December 2021 - New approvals are based on JUNIPERA trial data showing Cosentyx (secukinumab) demonstrated reduced flare risk versus placebo ...
Posted by Michael Wonder on 26 Dec 2021
Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA
23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...
Posted by Michael Wonder on 26 Dec 2021
Eagle Pharmaceuticals receives FDA approval for vasopressin
15 December 2021 - Company is first to file an ANDA referencing Vasostrict, which had total U.S. sales of $786 million ...
Posted by Michael Wonder on 26 Dec 2021
SIGA announces Health Canada regulatory approval of oral TPOXX
1 December 2021 - SIGA Technologies today announced that Health Canada has approved oral Tpoxx (tecovirimat) as an extraordinary use new ...
Posted by Michael Wonder on 26 Dec 2021
Takeda receives complete response letter from the U.S. FDA for TAK-721
21 December 2021 - Takeda today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 26 Dec 2021
GSK’s Jemperli (dostarlimab for injection) approved in Canada as an anti-PD-1 therapy for recurrent or advanced endometrial cancer
15 December 2021 - GSK announces today that it has been granted Notice of Compliance with conditions for its endometrial ...
Posted by Michael Wonder on 26 Dec 2021
Investigational Alzheimer’s disease therapy lecanemab granted FDA fast track designation
23 December 2021 - Eisai and Biogen announced today that lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of ...
Posted by Michael Wonder on 23 Dec 2021
FDA authorises first oral antiviral for treatment of COVID-19
22 December 2021 - Today, the U.S. FDA issued an emergency use authorisation for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, ...
Posted by Michael Wonder on 23 Dec 2021
FDA authorises additional oral antiviral for treatment of COVID-19 in certain adults
23 December 2021 - Today, the U.S. FDA issued an emergency use authorisation for Merck’s molnupiravir for the treatment of mild-to-moderate ...
Posted by Michael Wonder on 23 Dec 2021
Allarity Therapeutics submits new drug application to the U.S. FDA for dovitinib for third-line treatment of renal cell carcinoma
22 December 2021 - New drug application is supported by Allarity’s previously-filed pre-market approval submission to the FDA for the ...
Posted by Michael Wonder on 22 Dec 2021
Helsinn Group announces EMA acceptance for review of the marketing authorisation application for infigratinib for patients with cholangiocarcinoma with fibroblast growth factor receptor 2 fusions or rearrangements
21 December 2021 - Helsinn today announced that the EMA accepted for review the Company’s marketing authorisation application for infigratinib for ...
Posted by Michael Wonder on 22 Dec 2021
Intra-Cellular Therapies announces U.S. FDA approval of Caplyta (lumateperone) for the treatment of bipolar depression in adults
20 December 2021 - Caplyta is the only FDA approved treatment for depressive episodes associated with bipolar I or II ...
Posted by Michael Wonder on 22 Dec 2021
FDA approves Otezla (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of severity level
20 December 2021 - Otezla is the first and only oral therapy approved in adult patients with plaque psoriasis across all ...
Posted by Michael Wonder on 22 Dec 2021
Ultomiris regulatory submission accepted under FDA priority review in the US for adults with generalised myasthenia gravis
21 December 2021 - Submission based on positive Phase 3 trial in which Ultomiris significantly improved functional activities as measured ...