Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology.
The announcement coincided with remarks from the FDA's newly appointed CBER chief, who said the agency aims to return to a sense of normalcy and highlighted upcoming work on a weight loss medication that does not rely on GLP-1 mechanisms.
In related biotech news, Johnson & Johnson reported its second-quarter earnings, and a Phase 3 trial in China showed that the targeted chemotherapy sac-TMT combined with Merck's Keytruda delayed tumor progression and hinted at a survival advantage in first-line, PDL1-negative, non-squamous lung cancer patients.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: Celcuity’s breast cancer drug approved, its first”
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