In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...
Maharashtra CM Fadnavis on Wednesday directed the officials to improve healthcare services in and take action against food ...
MannKind expects to submit a request for a supplemental new drug application (sNDA) meeting with the U.S. Food and Drug Administration (FDA) in 1H 2025 to discuss the data and filing timeline.
Aquestive Therapeutics' Anaphylm is nearing FDA approval, potentially disrupting the U.S. anaphylaxis market dominated by ...
Kazia Therapeutics (KZIA) provided a regulatory update on paxalisib for the treatment of glioblastoma, GBM, following its Type C clinical meeting with the United States Food and Drug ...
On December 17, 2024, the Company conducted a Submission Issue Request (SIR) meeting with the FDA. Management believes its comprehensive plans to address the Additional Information Request (AIR ...
Kazia Therapeutics updates paxalisib's regulatory progress after FDA discussions on glioblastoma data, highlighting plans for ...
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