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

Aldeyra received an FDA CRL for reproxalap, necessitating an additional study for DED approval. Read why I continue to rate ...

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

She also offered strategies to streamline the process and reduce the strain on the developer ... the drug developer submits ...

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

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 ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

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

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

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

Former President Donald Trump has boasted in recent months about "Right To Try," a law he signed in 2018. It's aimed at ...