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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 29 Jan 2026
Cipher Pharmaceuticals announces Health Canada's acceptance for review of new drug submission for Natroba (spinosad)
28 January 2026 - Cipher Pharmaceuticals today announced that Health Canada has accepted for review Cipher's new drug submission for ...
Posted by Michael Wonder on 29 Jan 2026
Elevar Therapeutics submits new drug application to FDA for lirafugratinib as second-line treatment option for cholangiocarcinoma
28 January 2026 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 28 Jan 2026
Immix Biopharma receives US FDA breakthrough therapy designation for NXC-201
28 January 2026 - Breakthrough therapy designation granted to NXC-201 based on positive NEXICART-2 Phase 2 interim clinical results, presented at ...
Posted by Michael Wonder on 28 Jan 2026
Biogen’s litifilimab receives FDA breakthrough therapy designation for cutaneous lupus erythematosus, a disease with no targeted treatment options
28 January 2026 - Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result ...
Posted by Michael Wonder on 28 Jan 2026
Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults
27 January 2026 - The PDUFA target action date is 24 July 2026. ...
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 ...