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RSS FeedPosted by Michael Wonder on 29 Apr 2026
Canada becomes the first G7 country to approve a generic version of semaglutide
28 April 2026 - Today, Health Canada authorised a generic semaglutide injection. This is the first generic semaglutide authorised by Health ...
Posted by Michael Wonder on 28 Apr 2026
FDA approves Caplyta (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
27 April 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental new ddrug application based ...
Posted by Michael Wonder on 27 Apr 2026
Saphnelo approved in the US for subcutaneous self-administration as a new auto-injector for the treatment of systemic lupus erythematosus
27 April 2026 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once weekly auto-injector, ...
Posted by Michael Wonder on 27 Apr 2026
Novartis Rhapsido receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria
27 April 2026 - Novartis announced today that the European Commission approved Rhapsido (remibrutinib) for chronic spontaneous urticaria in adult patients ...
Posted by Michael Wonder on 25 Apr 2026
Highlights from 20-23 April 2026 CHMP meeting
24 April 2026 - The EMA’s CHMP recommended five medicines for approval at its April 2026 meeting. ...
Posted by Michael Wonder on 25 Apr 2026
Novartis receives positive CHMP opinion for Itvisma for spinal muscular atrophy
24 April 2026 - Novartis today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 25 Apr 2026
Grace Therapeutics provides regulatory update on new drug application for GTx-104
23 April 2026 - Grace Therapeutics today announced that the US FDA has issued a complete response letter for the Company’s ...
Posted by Michael Wonder on 25 Apr 2026
Arrowhead Pharmaceuticals receives positive CHMP opinion recommending approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome in Europe
24 April 2026 - The CHMP opinion is based on positive results from the Phase 3 PALISADE study where Redemplo ...
Posted by Michael Wonder on 25 Apr 2026
Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses
24 April 2026 - Recommendation based on the HERCULES phase 3 study which demonstrated that brain-penetrant Cenrifki (tolebrutinib) significantly delayed ...
Posted by Michael Wonder on 25 Apr 2026
Recommendations made by the PBAC – March 2026
24 April 2026 - Recommendations made by the PBAC in March 2026 relating to the listing of medicines on the ...
Posted by Michael Wonder on 23 Apr 2026
FDA approves first ever gene therapy for treatment of genetic hearing loss under National Priority Voucher Program
23 April 2026 - Groundbreaking AAV-based gene therapy offers potential treatment for patients with OTOF gene-associated severe-to-profound and profound hearing loss. ...
Posted by Michael Wonder on 23 Apr 2026
Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
22 April 2026 - The MHRA has today approved the medicine Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) ...
Posted by Michael Wonder on 23 Apr 2026
AbbVie provides update on trenibotulinumtoxinE (TrenibotE) biologics license application in the US
23 April 2026 - AbbVie today announced that it received a complete response letter from the US FDA regarding the ...
Posted by Michael Wonder on 23 Apr 2026
Otarmeni (lunsotogene parvec-cwha) approved by FDA as first and only gene therapy for genetic hearing loss; Regeneron to provide Otarmeni for free in the US
23 April 2026 - Regeneron Pharmaceuticals today announced the US FDA has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first ...
Posted by Michael Wonder on 23 Apr 2026
Labcorp launches FDA approved companion diagnostic to identify patients with ovarian cancer eligible for Keytruda
22 April 2026 - Labcorp today announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, the only companion ...