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RSS FeedPosted by Michael Wonder on 10 Aug 2024
Amneal receives US FDA approval for IPX203 for treatment of Parkinson’s disease to be launched as Crexont (carbidopa and levodopa) extended release capsules
7 August 2024 - Crexont commercial launch planned in September 2024. ...
Posted by Michael Wonder on 09 Aug 2024
Lykos Therapeutics announces complete response letter for midomafetamine capsules for PTSD
9 August 2024 - US FDA requests additional Phase 3 study. ...
Posted by Michael Wonder on 09 Aug 2024
FDA approves first nasal spray for treatment of anaphylaxis
9 August 2024 - Today, the US FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type ...
Posted by Michael Wonder on 09 Aug 2024
FDA approves first nalmefene hydrochloride auto-injector to reverse opioid overdose
7 August 2024 - Today, the US FDA approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known ...
Posted by Michael Wonder on 09 Aug 2024
Citius Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
8 August 2024 - Lymphir is expected to launch within the next five months. ...
Posted by Michael Wonder on 08 Aug 2024
Medicare finalises reimbursement rule for breakthrough medical devices
7 August 2024 - The Centers for Medicare and Medicaid Services has finalised its rule easing reimbursement for medical device ...
Posted by Michael Wonder on 08 Aug 2024
Neurogene announces RMAT designation for NGN-401 investigational gene therapy for Rett syndrome
7 August 2024 - Designation based on preliminary clinical evidence from ongoing NGN-401 clinical trial that shows potential to address unmet ...
Posted by Michael Wonder on 07 Aug 2024
Novartis receives FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy
8 August 2024 - Fabhalta achieved a 44% proteinuria reduction from baseline in Phase 3 APPLAUSE-IgAN interim analysis, compared with 9% ...
Posted by Michael Wonder on 07 Aug 2024
George Medicines files new drug application with FDA for novel low dose triple combination for treatment of hypertension following successful international Phase 3 development program
6 August 2024 - Two international Phase 3 clinical trials for the treatment of hypertension, versus dual therapy and placebo, met ...
Posted by Michael Wonder on 07 Aug 2024
Meta Pharmaceuticals announces FDA grants rare paediatric disease designation to META-001-PH for the treatment of primary hyperoxaluria
5 August 2024 - META Pharmaceuticals Inc. announced that the US FDA has granted rare paediatric disease designation to its investigational ...
Posted by Michael Wonder on 06 Aug 2024
FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
6 August 2024 - Today, the FDA approved vorasidenib (Voranigo, Servier Pharmaceuticals), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) ...
Posted by Michael Wonder on 06 Aug 2024
Attralus receives breakthrough therapy designation for its pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis
5 August 2024 - A Phase 3 study for 124I-evuzamitide in patients with suspected cardiac amyloidosis is anticipated to begin ...
Posted by Michael Wonder on 05 Aug 2024
FDA submission to expand minimum age for Xenoview
1 August 2024 - Polarean Imaging announces that it has submitted a new drug application supplement to the US FDA to ...
Posted by Michael Wonder on 04 Aug 2024
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
1 August 2024 - Over the past decades, US Congress enabled the US FDA to facilitate and expedite drug development for ...
Posted by Michael Wonder on 04 Aug 2024
Genomic medicines can cost $3 million a dose. How to make them affordable.
1 August 2024 - The treatments are marvels of innovation. Their pricing must be inventive, too. ...