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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 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 03 Aug 2024
FDA approves additional indication for Fibryga for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency, potentially ushering in a new standard of care
1 August 2024 - Octapharma has announced the expanded approval of fibryga, fibrinogen (human) lyophilised powder for Reconstitution, for fibrinogen replacement ...
Posted by Michael Wonder on 02 Aug 2024
FDA approves first gene therapy to treat adults with metastatic synovial sarcoma
2 August 2024 - The US FDA approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with ...
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 30 Jul 2024
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma
30 July 2024 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) in combination with bortezomib, lenalidomide, and ...
Posted by Michael Wonder on 30 Jul 2024
Alpha Cognition’s oral therapy Zunveyl receives FDA approval to treat Alzheimer's disease
29 July 2024 - The second oral therapy approved this decade, Zunveyl's dual MOA was designed to eliminate drug absorption in ...
Posted by Michael Wonder on 29 Jul 2024
Luye Pharma announces US FDA approval of Erzofri (paliperidone palmitate) extended release injectable suspension for treating schizophrenia and schizoaffective disorder
28 July 2024 - Luye Pharma today announced that the US FDA has approved the company's Erzofri (paliperidone palmitate) extended-release injectable ...
Posted by Michael Wonder on 27 Jul 2024
US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata
25 July 2024 - Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials. ...
Posted by Michael Wonder on 26 Jul 2024
Mirum’s Livmarli now approved for PFIC in patients 12 months and older
25 July 2024 - Mirum Pharmaceuticals today announced that the US FDA has approved a label expansion for Livmarli (maralixibat) oral ...
Posted by Michael Wonder on 26 Jul 2024
US FDA approves BioMarin's Brineura (cerliponase alfa) for children under 3 years with CLN2 disease
24 July 2024 - Now approved for children of all ages with CLN2 Batten disease, regardless of whether they yet ...
Posted by Michael Wonder on 23 Jul 2024
FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab)
22 July 2024 - Epysqli is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. ...
Posted by Michael Wonder on 19 Jul 2024
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults
18 July 2024 - Voquenza met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid ...
Posted by Michael Wonder on 19 Jul 2024
Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose
16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...