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- 78articles · 30d
- 3+ day agolatest article
- Aug 17, 2026earliest in window
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- 335avg words
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News
Reviews underway of first drug for rare disease MOGAD
3+ day, 23+ hour ago (417+ words) Patients with a rare autoimmune disease known as MOGAD could be just a few months away from having the first approved treatment. The FDA has just started a priority review of Roche's anti-IL-6 inhibitor Enspryng (satralizumab) for MOGAD – myelin oligodendrocyte…...
Novo Nordisk's IL-6 drug flunks two more heart trials
6+ day, 22+ hour ago (399+ words) Novo Nordisk has opted to discontinue two late-stage trials of IL-6 inhibitor ziltivekimab in heart failure, after an interim look at the data suggested they would be unlikely to show a positive result. The revelation – first reported by Endpoints – affects the…...
Novartis sets sights on new oral MS drug after phase 3 wins
1+ week, 5+ day ago (305+ words) Novartis' oral BTK inhibitor remibrutinib has shown efficacy in a pair of phase 3 trials in relapsing multiple sclerosis (RMS), setting up marketing applications and boosting the drug's blockbuster credentials. Data from the REMODEL-1 and REMODEL-2 trials showed that remibrutinib was…...
Novartis halts CAR-T trials after patient deaths
1+ week, 6+ day ago (360+ words) Novartis has paused eight clinical trials of its experimental CAR-T therapy rapcabtagene autoleucel (rap-cel or YTB323) after three patients died from a severe, life-threatening inflammatory condition. The CD19-directed CAR-T, which uses the same CAR construct as Novartis' already-marketed Kymriah (tisagenlecleucel), but…...
FDA issues novel nods for diabetes monitor, migraine lenses
2+ week, 5+ day ago (422+ words) The US FDA announced two De Novo marketing authorisations for novel medical devices this week: A continuous glucose monitor that also monitors Keytone levels from Abbott and a light-blocking lens for migraine sufferers from startup Avulux. Abbott's Libre Duo 10 Day…...
Ultragenyx wins FDA approval for first treatment targeting root cause of GSDIa
3+ week, 3+ day ago (384+ words) US biopharma Ultragenyx has secured its first gene therapy approval, with the FDA clearing GENGLYCOS as the first treatment designed to address the underlying cause of the ultra-rare metabolic disorder, glycogen storage disease type Ia (GSDIa). GSDIa is caused by…...
FDA greenlights Regeneron drug for rare bone disease
3+ week, 4+ day ago (365+ words) The FDA has officially granted approval for Regeron's garetosmab-grts, to be sold under the brand name Pasatru. A monoclonal anitbody that blocks the protein Activin A, Pasatru is the second treatment to be approved for the ultra-rare disease fibrodysplasia ossificans…...