Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...

Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...

Autolus Therapeutics has secured US Food and Drug Administration (FDA) approval for Aucatzyl (obecaktagene autoleucel ...

we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal ...

I noted that low-profit drugs often have just one or two domestic producers, making us vulnerable to supply disruptions from ...

there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...

The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical development. The potential benefits are substantial, including faster ...

Instead, they’re left wondering how their pets ended up hurt or dead, after getting a shot that was supposed to give them new ...

In a long-sought move, the US Food and Drug Administration on Thursday formally began the process of abandoning ... The decongestant was originally approved by the FDA in 1976, but it came to ...

At the center of this fight is how the FDA regulates a possible "functional cure" for Type 1 diabetes and determines who gets ...

Lyophilization plays a crucial role in successful biologic molecule development, but what is lyophilization – and how can it ...