Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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
MHRA approves licence extension for Novartis’ targeted therapy for advanced breast cancer patients in Great Britain
23 December 2021 - Piqray (alpelisib), in combination with fulvestrant, is approved for appropriate advanced breast cancer patients with a PIK3CA ...
Posted by Michael Wonder on 26 Dec 2021
Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council seeks additional data; aducanumab remains under review
22 December 2021 - Biogen and Eisai today announced that the First Committee on New Drugs of the Pharmaceutical Affairs ...
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 26 Dec 2021
Merck and Ridgeback’s molnupiravir, an investigational oral anti-viral COVID-19 treatment, receives special approval for emergency in Japan
24 December 2021 - Molnupiravir, first oral COVID-19 antiviral medicine to receive authorisation in the world, now authorised in U.S., U.K. ...
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 ...