Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 20 Feb 2024
European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis
19 February 2024 - Velsipity is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 ...
Posted by Michael Wonder on 19 Feb 2024
EMA publishes agenda for 19-22 February 2024 CHMP meeting
19 February 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 19 Feb 2024
VivaGel BV US FDA appeal outcome
19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in ...
Posted by Michael Wonder on 19 Feb 2024
Certa Therapeutics’ FT011 granted US FDA fast track for the treatment of systemic sclerosis
19 February 2024 - Certa Therapeutics today announces that the US FDA has granted fast track designation for its investigational therapy ...
Posted by Michael Wonder on 19 Feb 2024
Health Canada approves Remsima SC for the treatment of inflammatory bowel disease
18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...
Posted by Michael Wonder on 19 Feb 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated advanced non-squamous non-small cell lung cancer
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
Posted by Michael Wonder on 19 Feb 2024
Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) granted priority review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer
15 February 2024 - Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin ...
Posted by Michael Wonder on 18 Feb 2024
FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure
16 February 2024 - Today, the US FDA approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and ...
Posted by Michael Wonder on 18 Feb 2024
Sarepta Therapeutics announces US FDA acceptance of an efficacy supplement to expand the Elevidys indication
16 February 2024 - Priority review granted, with a review goal date of 21 June 2024. ...
Posted by Michael Wonder on 16 Feb 2024
FDA approves osimertinib with chemotherapy for EGFR mutated non-small-cell lung cancer
16 February 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca) with platinum-based chemotherapy for patients with locally advanced or ...
Posted by Michael Wonder on 16 Feb 2024
FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
Posted by Michael Wonder on 16 Feb 2024
Sibeprenlimab received US FDA breakthrough therapy designation for the treatment of immunoglobulin A nephropathy
16 February 2024 - Otsuka and Visterra announce that the US FDA has granted breakthrough therapy designation for the investigational drug ...
Posted by Michael Wonder on 16 Feb 2024
Japan first in the world to approve Dupixent for chronic spontaneous urticaria
16 February 2024 - Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to ...
Posted by Michael Wonder on 16 Feb 2024
Caliway received US FDA fast track designation for CBL-514 for the treatment of Dercum's disease
14 February 2024 - CBL-514 is the first drug to receive fast track designation for Dercum's disease treatment. ...
Posted by Michael Wonder on 15 Feb 2024
FDA approves tepotinib for metastatic non-small-cell lung cancer
15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...