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RSS FeedPosted by Michael Wonder on 21 Jul 2025
EMA publishes agenda for 21-24 July 2025 CHMP meeting
21 July 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jul 2025
Thousands could benefit from first immunotherapy for severe birch tree pollen allergy
21 July 2025 - We have recommended the first under the tongue tablet immunotherapy shown to build long-term tolerance to allergens, ...
Posted by Michael Wonder on 21 Jul 2025
Bristol Myers Squibb’s supplemental new drug application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally
21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...
Posted by Michael Wonder on 20 Jul 2025
New and expanded cheaper medicines for severe and life-threatening conditions
20 July 2025 - Australians with post-transplant cytomegalovirus, breast, bile duct and urothelial cancer now have access to new and expanded ...
Posted by Michael Wonder on 20 Jul 2025
Amivantamab in combination with lazertinib for the first-line treatment of patients with advanced EGFR mutation positive non-small cell lung cancer
4 July 2025 - The Department of Health and Social Care has NICE to produce guidance on the use of ...
Posted by Michael Wonder on 19 Jul 2025
MHRA approves adrenaline nasal spray - the first needle-free emergency treatment for anaphylaxis in the UK
18 July 2025 - The MHRA has today approved adrenaline nasal spray (EURneffy) to be used for the emergency treatment of ...
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
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
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 ...