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RSS FeedPosted by Michael Wonder on 24 Jul 2025
Clearside Biomedical announces approval of Xipere suprachoroidal treatment for uveitic macular oedema in Canada
23 July 2025 - Clearside Biomedical announced today that Health Canada has granted approval for Xipere (triamcinolone acetonide injectable suspension) ...
Posted by Michael Wonder on 24 Jul 2025
Commissioner's National Priority Voucher Pilot Program
22 July 2025 - Accelerated drug review for companies supporting US national interests. ...
Posted by Michael Wonder on 24 Jul 2025
Anzupgo (delgocitinib) cream is now the first and only FDA approved treatment for moderate to severe chronic hand eczema in adults
23 July 2025 - In Phase 3 clinical trials, patients experienced significant skin clearance along with marked relief from pain and ...
Posted by Michael Wonder on 23 Jul 2025
GSK announces extension of US FDA an review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma
23 July 2025 - New PDUFA date scheduled for 23 October 2025. ...
Posted by Michael Wonder on 23 Jul 2025
European Commission approves Imbruvica (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant
23 July 2025 - Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of ...
Posted by Michael Wonder on 23 Jul 2025
European Commission approves Roche’s Itovebi for people with ER positive, HER2 negative, advanced breast cancer with a PIK3CA mutation
23 July 2025 - Approval based on INAVO120 data showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with ...
Posted by Michael Wonder on 23 Jul 2025
Bavarian Nordic receives acceptance from Health Canada for review of the new drug submission for its chikungunya vaccine
22 July 2025 - Bavarian Nordic announced today that Health Canada has accepted for review the Company’s application for licensure ...
Posted by Michael Wonder on 22 Jul 2025
Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma
23 July 2025 - Replimune Group today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 22 Jul 2025
Health Canada approves Keytruda for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy
21 July 2025 - Approval is based on the results from Phase 3 KEYNOTE-A18/ENGOT-cx11/GOG-30472 ...
Posted by Michael Wonder on 22 Jul 2025
Bayer’s Nubeqa (darolutamide) receives EU approval in third indication for patients with advanced prostate cancer
21 July 2025 - Approval is based on positive results from the pivotal Phase 3 ARANOTE trial and reinforces darolutamide’s established ...
Posted 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
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 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 ...