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 U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...

Prokidney Corp. ( (PROK) ) has released its Q3 earnings. Here is a breakdown of the information Prokidney Corp. presented to its investors.

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

The US Food and Drug Administration (FDA) has awarded the second breakthrough therapy designation (BTD) to Johnson & ...

Watch out, Gilead and Novartis: there's a new CAR-T in town. Autolus is ready to hit the ground running after winning FDA approval for its Aucatzyl, a late entry to the heated CD19 CAR-T cell therapy ...

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 ...