Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 19 Jul 2025
Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi
16 July 2025 - Bio-Thera Solutions today announced that the US FDA has accepted its biologics license application for BAT2506, a ...
Posted by Michael Wonder on 19 Jul 2025
Knight Therapeutics announces filing of new drug submission for Crexont (carbidopa and levodopa) extended release capsules in Canada
18 July 2025 - Knight Therapeutics announced today that Knight's new drug submission for Crexont has been accepted for review ...
Posted by Michael Wonder on 18 Jul 2025
European Commission grants conditional approval of Ezmekly
18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults ...
Posted by Michael Wonder on 18 Jul 2025
Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics ...
Posted by Michael Wonder on 18 Jul 2025
Aldeyra Therapeutics announces FDA acceptance for review of reproxalap new drug application for the treatment of dry eye disease
17 July 2025 - PDUFA target action date 16 December 2025. ...
Posted by Michael Wonder on 18 Jul 2025
Public Summary Documents (first time decisions not to recommend and deferrals) – March 2025 PBAC meeting
18 July 2025 - The Public Summary Documents (first-time decisions not to recommend and deferrals) from the March 2025 PBAC ...
Posted by Michael Wonder on 18 Jul 2025
Outcome statement - June 2025 DUSC meeting
18 July 2025 - The outcome statement from the June 2025 DUSC meeting is now available. ...
Posted by Michael Wonder on 18 Jul 2025
Johnson & Johnson receives US FDA priority review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer
17 July 2025 - New drug application supported by results from the Phase 2b SunRISe-1 study. ...
Posted by Michael Wonder on 18 Jul 2025
Praxis Precision Medicines receives FDA breakthrough therapy designation for relutrigine for the treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies
17July 2025 - The breakthrough therapy designation was granted based on the highly compelling results from the Phase 2 EMBOLD trial ...
Posted by Michael Wonder on 18 Jul 2025
Pierre Fabre announces transfer of investigational new drug application for tabelecleucel from Atara Biotherapeutics
15 July 2025 - Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program. ...
Posted by Michael Wonder on 18 Jul 2025
ICER publishes evidence report on treatments for spinal muscular atrophy
17 July 2025 - There are many remaining uncertainties around the best management of spinal muscular atrophy; ICER estimates that ...
Posted by Michael Wonder on 17 Jul 2025
Enhertu plus pertuzumab granted breakthrough therapy designation in the US as first-line therapy for patients with HER2 positive metastatic breast cancer
17 July 2025 - Ninth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast09 ...
Posted by Michael Wonder on 17 Jul 2025
US FDA approves GSK’s Shingrix in a pre-filled syringe presentation
17 July 2025 - Pre-filled syringe presentation offers a convenient administration option to health care professionals. ...
Posted by Michael Wonder on 17 Jul 2025
Thousands more breast cancer patients to benefit from new NHS treatment
17 July 2025 - NICE approves ribociclib combination therapy to help prevent cancer returning in early stage disease. ...
Posted by Michael Wonder on 17 Jul 2025
Eli Lilly calls out Korea as Verzenio’s $36K cost threatens cure window
17 July 2025 - While Eli Lilly’s Verzenio (abemaciclib) continues to rack up global sales on the strength of its ...