FDA’s approval of Bristol-Myers Squibb’s metastatic melanoma immunotherapy was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.
FDA’s approval of Bristol-Myers Squibb Co.'s metastatic melanoma immunotherapy Yervoy (ipilimumab) was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.
Faced with an application for a second-line indication and a single study showing a survival benefit, but with only modest...
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India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.
England is set to become the first market outside of the US where Autolus’ CAR-T therapy Aucatzyl is reimbursed for acute lymphoblastic leukemia, after the country’s health technology assessment institution, NICE, recommended its use for certain patients.
The US FDA’s Oncology Center of Excellence is eager to work with osteosarcoma researchers to advance trials for the difficult to study cancer – but OCE officials made clear that they are not likely to use mandatory pediatric study authorities to force the issue.
The orphan drug share of US FDA’s 2025 novel approvals is holding steady, with examples of approvals based on a single trial with confirmatory evidence from UCB, Precigen, Jazz Pharmaceuticals and Stealth Biotherapeutics
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.
