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RSS FeedPosted by Michael Wonder on 15 Apr 2026
Aligos Therapeutics announces first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection and grant of FDA fast track designation
14 April 2026 - Aligos Therapeutics today announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir ...
Posted by Michael Wonder on 15 Apr 2026
Praxis Precision Medicines announces FDA acceptance of new drug application for ulixacaltamide hydrochloride in patients with essential tremor
14 April 2026 - - Praxis Precision Medicines today announced that the US FDA has accepted for review its new drug ...
Posted by Michael Wonder on 15 Apr 2026
My brother can’t access a just approved breakthrough drug for his rare disease
14 April 2026 - A new therapy for Hunter syndrome highlights the inequities of age-based approvals. ...
Posted by Michael Wonder on 15 Apr 2026
Renaissance Pharma secures FDA fast track designation for daretabart (hu1418K322A) in high risk neuroblastoma
14 April 2026 - Renaissance Pharma Limited, an Essential Pharma company, today announces that the US FDA has granted fast track ...
Posted by Michael Wonder on 15 Apr 2026
US FDA grants RMAT designation to GS-100, Grace Science’s gene therapy to treat NGLY1 deficiency
14 April 2026 - Grace Science announced today that the US FDA has granted regenerative medicine advanced therapy designation to GS-100 ...
Posted by Michael Wonder on 14 Apr 2026
Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the first and only approved medicine for FSGS
13 April 2026 - Travere Therapeutics today announced that the US FDA has approved Filspari (sparsentan) to reduce proteinuria in adult ...
Posted by Michael Wonder on 14 Apr 2026
Saphnelo subcutaneous approved in Canada for the treatment of systemic lupus erythematosus
13 April 2026 - Health Canada has granted a notice of compliance for Saphnelo (anifrolumab injection) for subcutaneous self-administration via a ...
Posted by Michael Wonder on 14 Apr 2026
Kymera Therapeutics announces US FDA fast track designation for KT-621, a first in class, oral STAT6 degrader for the treatment of moderate to severe asthma
13 April 2026 - Kymera Therapeutics today announced that the US FDA has granted fast track designation to KT-621, its ...
Posted by Michael Wonder on 13 Apr 2026
Dupixent (dupilumab) approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria
13 April 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the European Commission has approved Dupixent (dupilumab) for the treatment ...
Posted by Michael Wonder on 13 Apr 2026
Ifinatamab deruxtecan granted priority review in the US for adult patients with previously treated extensive-stage small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy
13 April 2026 - Based on results from IDeate-Lung01 Phase 2 trial, with support from IDeate-PanTumor01 Phase 1/2 trial. ...
Posted by Michael Wonder on 11 Apr 2026
FDA approves updated Vabysmo label to extend treatment for macular oedema following retinal vein occlusion beyond six months
9 April 2026 - Genentech has received US FDA approval of Vabysmo (faricimab-svoa) for the treatment of macular oedema due to ...
Posted by Michael Wonder on 10 Apr 2026
Celltrion’s ADC candidate CT-P71 wins FDA fast track in urothelial cancer
9 April 2026 - Celltrion announced Thursday that the US FDA has granted fast track designation to its antibody-drug conjugate ...
Posted by Michael Wonder on 10 Apr 2026
FDA accepts NDA for TLX101-Px (Pixclara)
10 April 2026 - Telix today announces that the US FDA has accepted the Company’s resubmitted new drug application for TLX101-Px, ...
Posted by Michael Wonder on 10 Apr 2026
Wegovy injection becomes first GLP-1 weight-loss treatment approved for 48-hour controlled-temperature delivery in the EU
9 April 2026 - – The EMA has approved an update to the product information for Wegovy injection that allows ...
Posted by Michael Wonder on 10 Apr 2026
Replimune receives complete response letter from the FDA for RP1 biologics license application for the treatment of advanced melanoma
10 April 2026 - Replimune Group today announced that the company received a complete response letter from the US FDA ...