Blog
RSS FeedPosted by Michael Wonder on 19 Apr 2024
US FDA approves subcutaneous administration of Takeda’s Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
19 April 2024 - Entyvio is now available in the US in both intravenous and subcutaneous administrations for maintenance treatment ...
Posted by Michael Wonder on 18 Apr 2024
FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK positive early stage lung cancer
18 April 2024 - Approval based on Phase 3 ALINA study showing Alecensa reduced the risk of disease recurrence or death ...
Posted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
Posted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
Posted by Michael Wonder on 12 Apr 2024
Formycon announces commercial launch of FYB201 (ranibizumab) in Canada (Ranopto) and Switzerland (Ranivisio)
11 April 2024 - Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto and in Switzerland under the trademark ...
Posted by Michael Wonder on 11 Apr 2024
PureTech receives FDA fast track designation for LYT-200 in head and neck cancers
11 April 2024 - LYT-200 is being evaluated in locally advanced/metastatic solid tumours, including head and neck cancers, as well as ...
Posted by Michael Wonder on 11 Apr 2024
Fasenra approved for treatment of children aged 6 to 11 with severe asthma
11 April 2024 - AstraZeneca’s Fasenra (benralizumab) is now approved by the US FDA for add-on maintenance treatment for patients ...
Posted by Michael Wonder on 10 Apr 2024
AdrenoMed receives FDA fast track designation for enibarcimab for treatment of septic shock
10 April 2024 - AdrenoMed today announced that the US FDA has granted fast track designation to its lead product candidate ...
Posted by Michael Wonder on 10 Apr 2024
AB Science announces that Health Canada has granted eligibility for reconsideration request for masitinib in ALS
3 April 2024 - AB Science today announced that Health Canada has granted eligibility for reconsideration request for masitinib in ...
Posted by Michael Wonder on 10 Apr 2024
FDA accepts filing of new drug application for nalmefene auto-injector for the treatment of known or suspected opioid overdose
8 April 2024 - Purdue Pharma announced today that FDA has accepted for filing the company’s new drug application for the ...
Posted by Michael Wonder on 10 Apr 2024
Lundbeck and Otsuka submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD
9 April 2024 - Lundbeck and Otsuka have submitted a supplemental new drug application for US FDA review of brexpiprazole ...
Posted by Michael Wonder on 09 Apr 2024
Syros receives fast track designation from the FDA for tamibarotene for the treatment of newly diagnosed unfit AML with RARA gene over-expression
9 April 2024 - Syros Pharmaceuticals today announced that the US FDA has granted fast track designation to tamibarotene in ...
Posted by Michael Wonder on 09 Apr 2024
Using effect scores to characterise heterogeneity of treatment effects
9 April 2024 - It is common for treatments to yield different outcomes in different patients. If patient characteristics that predict ...
Posted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 09 Apr 2024
Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukaemia and other cancers
8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024. ...