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 ...

PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

The FDA has scuttled Merus’ plans to win a speedy approval for i | The FDA has scuttled Merus’ plans to win a speedy approval ...

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...

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 ...

An analysis of SpringWorks Therapeutics, Inc., including recent FDA approval, promising sales, and future funding for ...

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 ...