If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for ...

The FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR ...

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), ...

The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim ...

Merck (MRK) announced the FDA has accepted the Biologics License Application for clesrovimab, or MK-1654, the company's ...

The FDA delays Johnson & Johnson's SC amivantamab approval for NSCLC over facility inspection issues, unrelated to product ...

These results, along with the potential for a Biologics License Application (BLA) submission in the second half of 2025 and a possible launch in the second half of 2026, strengthen the drug’s profile.

Adult clinical trials found that Tremfya could treat plaque psoriasis by 16 weeks. Follow-up analysis found that roughly 23% ...

Lilly has been instrumental in supplying its API for insulin at a low cost and offering technology transfer to EVA.

Merck & Co Inc (NYSE:MRK) revealed that it would discontinue the clinical development programs for vibostolimab and ...

Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment ...

The company is advancing its Phase I/II trial and exploring accelerated approval pathways in the US and Europe.