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RSS FeedPosted by Michael Wonder on 06 Nov 2025
FDA approval of Caplyta (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
6 November 2025 - Johnson & Johnson announced today that the US FDA approved Caplyta (lumateperone) as an adjunctive therapy with ...
Posted by Michael Wonder on 06 Nov 2025
Hikma Pharmaceuticals announces the launch of Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) injection
6 November 2025 - Hikma Pharmaceuticals today announced the launch of Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection. ...
Posted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) ...
Posted by Michael Wonder on 06 Nov 2025
argenx announces Vvygart SC pre-filled syringe for self-Injection in chronic inflammatory demyelinating polyneuropathy authorised for sale by Health Canada
5 November 2025 - argenx today announced that Health Canada has issued a Notice of Compliance authorising Vvyvart SC (efgartigimod alfa ...
Posted by Michael Wonder on 05 Nov 2025
Advicenne has submitted to US FDA the registration application for Sibnayal in dRTA treatment
4 November 2025 - Advicenne announces the submission of the registration application for Sibnayal (fixed-dose combination of potassium citrate and ...
Posted by Michael Wonder on 05 Nov 2025
FDA issues complete response letter for Biohaven's Vyglyxia (troriluzole) new drug application for spinocerebellar ataxia
4 November 2025 - Biohaven today announced that it has received a complete response letter from the US FDA for the ...
Posted by Michael Wonder on 05 Nov 2025
AstraZeneca’s Ultomiris gets insurance benefits for neuromyelitis optica spectrum disorders
4 November 2025 - AstraZeneca Korea announced on Monday that the C5 complement inhibitor Ultomiris (ravulizumab) has been covered by ...
Posted by Michael Wonder on 04 Nov 2025
Chiesi Global Rare Diseases and Protalix BioTherapeutics seek re-examination from the EMA for the negative opinion for Elfabrio (pegunigalsidase alfa) alternative dosing regimen of every four weeks in the EU
3 November 2025 - Every two weeks remains approved as a dosing regimen of Elfabrio in the EU. ...
Posted by Michael Wonder on 04 Nov 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010
3 November 2025 - Outlook Therapeutics today announced it has resubmitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 04 Nov 2025
US FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo (denosumab-bmwo) and Ozenvelt (denosumab-bmwo)
30 October 2025 - The US FDA approved Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable with the reference products Prolia (denosumab) ...
Posted by Michael Wonder on 04 Nov 2025
Benitec Biopharma receives FDA fast track designation for BB-301
3 November 2025 - Benitec Biopharma today provides positive interim clinical results for the BB-301 Phase 1b/2a clinical trial. ...
Posted by Michael Wonder on 03 Nov 2025
Viridian Therapeutics announces successful October submission of biologics license application to US FDA for veligrotug in thyroid eye disease
3 November 2025 - Viridian Therapeutics today announced the successful October submission of its biologics license application to the US FDA ...
Posted by Michael Wonder on 03 Nov 2025
US FDA approves Kygevvi (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency
3 November 2025 - UCB today announced that Kygevvi has been granted approval by the US FDA for the treatment ...
Posted by Michael Wonder on 03 Nov 2025
Alvotech provides update on the status of US biologics license application for AVT05
2 November 2025 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 02 Nov 2025
DoH publishes revised agenda for November 2025 PBAC meeting (version 6)
31 October 2025 - The DoH has published a revised agenda for the November 2025 PBAC meeting. ...