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RSS FeedPosted by Michael Wonder on 11 Jun 2026
Italfarmaco announces Health Canada acceptance and priority review of new drug submission for givinostat as a Duchenne muscular dystrophy treatment
10 June 2026 - New drug submission is based on Italfarmaco’s Phase 3 EPIDYS trial data demonstrating meaningful treatment benefits ...
Posted by Michael Wonder on 13 May 2026
FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
13 May 2026 - Today, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), a BCL-2 inhibitor, for adults ...
Posted by Michael Wonder on 13 May 2026
European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors
13 May 2026 - Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication ...
Posted by Michael Wonder on 13 May 2026
Kyverna Therapeutics announces initiation of rolling SPS BLA submission
12 May 2026 - The Company has initiated its rolling BLA submission, seeking priority review under the program's regenerative medicine advanced ...
Posted by Michael Wonder on 13 May 2026
BridgeBio submits NDA to FDA for encaleret for individuals living with ADH1
12 May 2026 - BridgeBio Pharma today announced the submission of its new drug application to the FDA for encaleret as ...
Posted by Michael Wonder on 13 May 2026
Agios submits sNDA to FDA for US accelerated approval of mitapivat in sickle cell disease
12 May 2026 - Agios Pharmaceuticals today announced the submission of its supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 12 May 2026
Coya Therapeutics has been granted US FDA fast track designation for COYA 302 for the treatment of amyotrophic lateral sclerosis
12 May 2026 - Coya Therapeutics today announced that the US FDA has granted fast track designation for COYA 302, ...
Posted by Michael Wonder on 12 May 2026
Emiltatug ledadotin granted breakthrough therapy designation by the US FDA for adenoid cystic carcinoma
12 May 2026 - Servier today announced that the US FDA has granted breakthrough therapy designation to emiltatug ledadotin, an investigational ...
Posted by Michael Wonder on 12 May 2026
FDA advances drug repurposing to address unmet medical needs
11 May 2026 - Agency is particularly focused on new uses to treat chronic or rare diseases. ...
Posted by Michael Wonder on 12 May 2026
Sironax’s SARM1 inhibitor SIR2501 granted FDA fast track designation in chemotherapy-induced peripheral neuropathy
11 May 2026 - Sironax today announced that the US FDA has designated its SARM1 inhibitor SIR2501 as a fast track ...
Posted by Michael Wonder on 11 May 2026
Zai Lab receives US FDA fast track designation for zocilurtatug pelitecan (Zoci), a DLL3 targeting ADC, for treatment of extrapulmonary neuroendocrine carcinomas
11 May 2026 - Zai Lab today announced the US FDA has granted fast track designation to zocilurtatug pelitecan (zoci, formerly ...
Posted by Michael Wonder on 09 May 2026
Lilly's Retevmo moves closer to Korea reimbursement coverage after key review approval
8 May 2026 - Retevmo (selpercatinib), a targeted therapy for RET gene mutation-driven cancers, has cleared a major hurdle toward ...
Posted by Michael Wonder on 09 May 2026
argenx announces US FDA approval expanding Vyvgart and Vyvgart Hytrulo for use in all adult patients living with gMG
8 May 2026 - argenx today announced the US FDA approved a label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo ...
Posted by Michael Wonder on 09 May 2026
Vertex announces Casgevy reimbursement agreement for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia in Germany
6 May 2026 - The agreement ensures sustainable access to this innovative therapy for eligible patients ages 12 years and ...
Posted by Michael Wonder on 09 May 2026
Update from the PBAC (April 2026)
7 May 2026 - The PBAC has published its April 2026 update. ...
Posted by Michael Wonder on 08 May 2026
Update to agenda for the July 2026 PBAC meeting (8 May 2026)
8 May 2026 - The agenda for the July 2026 PBAC meeting has now been updated. ...