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 ...

Pfizer ’s executive team is using Mar-a-Lago for a planning meeting over several days, the people said. While there is no scheduled meeting between Bourla and Trump, the pair are likely to interact ...

A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...

Aquestive Therapeutics' Anaphylm is nearing FDA approval, potentially disrupting the U.S. anaphylaxis market dominated by ...

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.

If Altimmune can't find a partner or be acquired, then a hefty fund raise awaits investors, which could hit the stock. Click ...

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 ...