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 28 Jan 2026
Novel drug approvals for 2025
23 January 2026 - In 2025, the CDER approved 46 new drugs never before approved or marketed in the US, known ...
Posted by Michael Wonder on 28 Jan 2026
The European Commission extended the marketing authorisation for Vueway (gadopiclenol) in the European Union for use in paediatric patients under 2 years of age
27 January 2026 - Bracco Imaging announces that on 23 January 2026, the European Commission amended the Marketing Authorisation for Vueway ...
Posted by Michael Wonder on 28 Jan 2026
MHRA takes over Chair of International Access Consortium for 2026
26 January 2026 - The MHRA has formally begun its year as chair of the Access Consortium for 2026, marking ...
Posted by Michael Wonder on 28 Jan 2026
New hope for people with breathing condition, COPD, as NICE approves innovative treatment
26 January 2026 - Almost 30,000 people in England with a respiratory disease called COPD (chronic obstructive pulmonary disease) could ...
Posted by Michael Wonder on 27 Jan 2026
Innovent announces IBI3003 (GPRC5D/BCMA/CD3 trispecific antibody) receives fast track designation from the US FDA for relapsed or refractory multiple myeloma
27 January 2026 - Innovent Biologics announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received fast track designation from the US ...
Posted by Michael Wonder on 27 Jan 2026
Drug Farm announces FDA fast track designation for first in class ALPK1 inhibitor DF-003 for the treatment of ROSAH syndrome
27 January 2026 - Drug Farm today announced that the US FDA has granted fast track designation to DF-003, its investigational, ...
Posted by Michael Wonder on 27 Jan 2026
EMA publishes agenda for 26-29 January 2026 CHMP meeting
26 January 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 Jan 2026
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
27 January 2026 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, lenalidomide, ...
Posted by Michael Wonder on 27 Jan 2026
Libevitug approved in China as first in class treatment for hepatitis D
27 January 2026 - Huahui Health announced that China NMPA has granted conditional approval to its Libevitug injection for the treatment ...
Posted by Michael Wonder on 27 Jan 2026
Eisai submits marketing authorisation variation to EMA for intravenous maintenance dosing every four weeks with Leqembi (lecanemab)
26 January 2026 - BioArctic AB's partner Eisai announced today that they have submitted a proposed marketing authorisation variation to the ...
Posted by Michael Wonder on 27 Jan 2026
Health Canada authorises Gazyva (obinutuzumab) for adults with active lupus nephritis
26 January 2026 - Roche Canada is pleased to announce that on 22 January 2026, Health Canada has approved Gazyva ...
Posted by Michael Wonder on 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license ...
Posted by Michael Wonder on 27 Jan 2026
MannKind announces FDA approval of updated Afrezza label providing starting dose guidance when switching from multiple daily injections or insulin pump mealtime therapy
26 January 2026 - Updated initial conversion table based on clinical trials in adults showing significantly improved mealtime glycemic excursions. ...
Posted by Michael Wonder on 27 Jan 2026
Novo's Ozempic to gain insurance coverage for diabetes in Korea from February under new criteria
23 January 2026 - Starting in February, Korea's national health insurance will cover Novo Nordisk's Ozempic pre-filled pen, which contains ...
Posted by Michael Wonder on 26 Jan 2026
Cogent Biosciences announces breakthrough therapy designation for bezuclastinib in combination with sunitinib for patients with gastro-intestinal stromal tumours
26 January 2026 - Cogent will submit the PEAK new drug application under previously announced RTOR designation; on track to complete ...