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RSS FeedPosted by Michael Wonder on 23 Jul 2025
DualityBio's next generation HER3 ADC DB-1310 granted FDA fast track designation
21 July 2025 - DualityBio announced that the US FDA has granted fast track designation to its next-generation HER3 targeting antibody ...
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
Johnson & Johnson seeks first icotrokinra US FDA approval aiming to revolutionise treatment paradigm for adults and adolescents with plaque psoriasis
21 July 2025 - Icotrokinra is a first in class investigational targeted oral peptide that selectively blocks the IL-23 receptor. ...
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 22 Jul 2025
ProMIS Neurosciences granted fast track designation by US FDA for PMN310 in the treatment of Alzheimer’s disease
21 July 2025 - ProMIS Neurosciences today announced that the US FDA has granted fast track designation to PMN310, the ...
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 20 Jul 2025
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-A601 gene therapy for PKP2 arhythmogenic cardiomyopathy
17 July 2025 - -- Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 20 Jul 2025
Genascence announces US FDA grants regenerative medicine advanced therapy designation to GNSC-001 for knee osteoarthritis
16 July 2025 - Genascence Corporation today announced that the US FDA has granted the regenerative medicine advanced therapy designation ...
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 ...