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RSS FeedPosted by Michael Wonder on 09 Aug 2024
FDA approves first nalmefene hydrochloride auto-injector to reverse opioid overdose
7 August 2024 - Today, the US FDA approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known ...
Posted by Michael Wonder on 09 Aug 2024
Citius Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
8 August 2024 - Lymphir is expected to launch within the next five months. ...
Posted by Michael Wonder on 07 Aug 2024
Novartis receives FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy
8 August 2024 - Fabhalta achieved a 44% proteinuria reduction from baseline in Phase 3 APPLAUSE-IgAN interim analysis, compared with 9% ...
Posted by Michael Wonder on 07 Aug 2024
George Medicines files new drug application with FDA for novel low dose triple combination for treatment of hypertension following successful international Phase 3 development program
6 August 2024 - Two international Phase 3 clinical trials for the treatment of hypertension, versus dual therapy and placebo, met ...
Posted by Michael Wonder on 07 Aug 2024
Meta Pharmaceuticals announces FDA grants rare paediatric disease designation to META-001-PH for the treatment of primary hyperoxaluria
5 August 2024 - META Pharmaceuticals Inc. announced that the US FDA has granted rare paediatric disease designation to its investigational ...
Posted by Michael Wonder on 06 Aug 2024
FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
6 August 2024 - Today, the FDA approved vorasidenib (Voranigo, Servier Pharmaceuticals), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) ...
Posted by Michael Wonder on 04 Aug 2024
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
1 August 2024 - Over the past decades, US Congress enabled the US FDA to facilitate and expedite drug development for ...
Posted by Michael Wonder on 03 Aug 2024
FDA has accepted a BLA for bentracimab, the first and only ticagrelor reversal agent, for filing and priority review
2 August 2024 - SFJ Pharmaceuticals, sponsor of the bentracimab biologics license application, and SERB Pharmaceuticals (SERB), who acquired exclusive ...
Posted by Michael Wonder on 03 Aug 2024
Bayer submits new drug application to US FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause
1 August 2024 - The new drug application includes data from the Phase 3 studies OASIS 1, 2 and 3 ...
Posted by Michael Wonder on 02 Aug 2024
Supernus resubmits NDA for SPN-830 apomorphine infusion device
1 August 2024 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...
Posted by Michael Wonder on 01 Aug 2024
FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy
1 August 2024 - Today, the FDA approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for ...
Posted by Michael Wonder on 01 Aug 2024
Corvus Pharmaceuticals granted FDA fast track designation for soquelitinib for treatment of patients with relapsed or refractory peripheral T-cell lymphoma
1 August 2024 - Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3, 2024. ...
Posted by Michael Wonder on 01 Aug 2024
Achieve Life Sciences announces FDA grants breakthrough therapy designation to cytisinicline for the treatment of e-cigarette or vaping nicotine dependence
31 July 2024 - Achieve Life Sciences announced today that the US FDA has granted breakthrough therapy designation for cytisinicline for ...
Posted by Michael Wonder on 01 Aug 2024
Immuneering granted FDA fast track designation for IMM-1-104 in first-line pancreatic cancer
31 July 2024 - IMM-1-104 fast track designation now granted for the treatment of both first and second-line pancreatic ductal adenocarcinoma. ...
Posted by Michael Wonder on 31 Jul 2024
PTC Therapeutics announces sepiapterin NDA submission to FDA
30 July 2024 - PTC Therapeutics announced today the submission of the sepiapterin new drug application to the US FDA. ...