The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...

The U.S. Food and Drug Administration has approved Insmed's oral drug for a type of lung disease, the company said on Tuesday ...

Novel drugs typically go through the New Drug Application (NDA) or Biologics License Application (BLA) process, which involves clinical trials to show they’re safe and effective.

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response ...

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

After a decade of development, a Kansas City-based pharmaceutical company is on the brink of submitting its ADHD medication ...

AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 ...

SHELTON, CT / ACCESS Newswire / July 30, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the ...

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

Johnson & Johnson (NYSE:JNJ) is one of the best trade‑war resistant stocks to buy now. On July 21, 2025, J&J submitted a New ...