The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the company’s  “new drug applications” for lencapavir, a twice-yearly ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early ... needed for the IRB and/or FDA to make a determination. Learn more on the FDA process Here is where differences ...

In a Phase Ib trial, 71 percent of patients responded to zongertinib and lived a median six months before disease progression or death.

On October 29, 1959, the pharmaceutical company G.D. Searle filed an application with the U.S ... In 1959 the main hurdle to FDA approval for any new drug was that it be proven safe.

The spike followed news that the U.S. Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA ... expediting the review process due to its potential to address ...

In September of 2023 Vanda submitted a New Drug Application (NDA) seeking approval by the FDA. In September of 2024 the FDA rejected the application via a Complete Response Letter, suggesting that ...

for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who ...