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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 08 Jan 2026
FDA approves new 2 gram presentation of Fibryga, enhancing convenience and precision in treating acquired fibrinogen deficiency
7 January 2026 - Octapharma today announced that the US FDA has approved a new 2 g presentation of Fibryga, fibrinogen ...
Posted by Michael Wonder on 08 Jan 2026
Vera Therapeutics announces US FDA granted priority review to biologics license application for atacicept for treatment of adults with IgA nephropathy
7 January 2026 - Vera Therapeutics today announced the atacicept biologics license application for the treatment of adults with immunoglobulin A ...
Posted by Michael Wonder on 07 Jan 2026
Biosplice announces the submission of its new drug application to the FDA for lorecivivint to treat knee osteoarthritis
6 January 2026 - Biosplice Therapeutics announced today that it has submitted its new drug application to the FDA for approval ...
Posted by Michael Wonder on 07 Jan 2026
Maviret receives Health Canada approval for the treatment of acute hepatitis C virus
6 January 2026 - Maviret received approval through Health Canada's priority review process, based on data from the Phase 3 M20-350 ...
Posted by Michael Wonder on 07 Jan 2026
Milestone Pharmaceuticals announces acceptance of marketing authorisation application for etripamil nasal spray in PSVT by the EMA
6 January 2026 - Milestone Pharmaceuticals today announced the acceptance of a marketing authorisation application by the EMA seeking the approval ...
Posted by Michael Wonder on 07 Jan 2026
Johnson & Johnson submits application to the EMA for Tecvayli (teclistamab) in combination with Darzalex (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
5 January 2026 - The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement ...
Posted by Michael Wonder on 07 Jan 2026
Korea’s next homegrown drug could be a first local CAR-T as payer keeps widening access
6 January 2026 - Korea spent 2025 doing something it has not always been quick to do: it paid for ...
Posted by Michael Wonder on 06 Jan 2026
Oculis announces US FDA breakthrough therapy designation granted to privosegtor for treatment of optic neuritis
6 January 2026 - Oculis today announced that its neuroprotective candidate privosegtor was granted breakthrough therapy designation by the US FDA ...
Posted by Michael Wonder on 06 Jan 2026
Alixorexton granted breakthrough therapy designation by US FDA for the treatment of narcolepsy type 1
6 January 2026 - Alkermes today announced that the US FDA has granted breakthrough therapy designation to alixorexton for the ...
Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for ...
Posted by Michael Wonder on 06 Jan 2026
NICE recommends new treatment option for highly active multiple sclerosis
2 January 2026 - Thousands of people living with a form of multiple sclerosis will benefit from greater treatment choice, following ...
Posted by Michael Wonder on 06 Jan 2026
Idorsia’s Jeraygo (aprocitentan) approved in Canada for the treatment of resistant hypertension
5 January 2026 - Idorsia announces that Health Canada has granted marketing authorisation for Jeraygo (aprocitentan) for the treatment of resistant ...
Posted by Michael Wonder on 06 Jan 2026
Arrowhead Pharmaceuticals announces Health Canada approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
5 January 2026 - The Health Canada approval is based on positive results from the Phase 3 PALISADE study where Redemplo ...
Posted by Michael Wonder on 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...
Posted by Michael Wonder on 05 Jan 2026
Altimmune receives FDA breakthrough therapy designation for pemvidutide in MASH
5 January 2026 - Alignment on Phase 3 registrational trial parameters confirmed following receipt of minutes from end of phase 2 ...