News

US FDA approves Jazz Pharmaceuticals’ Modeyso to treat recurrent H3 K27M-mutant diffuse midline glioma: Dublin Friday, August 8, 2025, 11:00 Hrs [IST] Jazz Pharmaceuticals plc, ...
Analysis leads to FDA RMAT submission and late-breaking abstract for implantable cell therapy - NEWARK, Del., Aug. 7, 2025 ...
Modeyso is the first and only approved treatment for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one ...
The Trump administration has proposed new drone regulations that will eliminate case-by-case approval processes for beyond visual line of sight (BVLOS)  operations, while Acting NASA Administrator ...
Modeyso is the first drug to treat patients with diffuse midline glioma with an H3 K27M mutation, an ultra-rare and aggressive brain tumor.
The FDA granted accelerated approval to dordaviprone for the treatment of patients aged 1 year and older with recurrent diffuse midline glioma who harbor the H3 K27M mutation with progressive disease ...
Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...
The FDA has granted accelerated approval to Modeyso (dordaviprone) for the treatment of certain patients with diffuse midline glioma.
Jazz Pharmaceuticals bet $1 billion on the commercial potential of a first-in-class oral imipridone for recurrent H3 K27M-mutant diffuse glioma.
The FDA granted accelerated approval to dordaviprone (Modeyso) as the first systemic therapy for adults and children with ...
The FDA has granted accelerated approval to dordaviprone for use in adult and pediatric patients with H3 K27M-mutated diffuse midline glioma.
FDA accelerates approval of dordaviprone, the first targeted therapy for aggressive diffuse midline glioma, offering hope for ...