AstraZeneca AZN announced that the FDA has expanded the label of its cancer drug Datroway for a second indication — non-small ...

FDA updates talazoparib and enzalutamide labeling, confirming survival benefits for HRR-mutated mCRPC, while excluding ...

A Texas law promoting the Trump administration’s “Make America Healthy Again” agenda requires first-ever warning labels on ...

FDA approved to help select patients with metastatic prostate cancer for radioligand therapy before chemotherapy.

The Food and Drug Administration (FDA) has granted accelerated approval to Datroway ® (datopotamab deruxtecan-dlnk) for adults with locally advanced or metastatic epidermal growth factor receptor ...

Industry experts note some naturally derived ingredients would also require disclosures, leading to consumer confusion.

Incyte INCY announced that the FDA has extended the review period for the supplemental new drug application (sNDA) for ...

FDA accelerates approval of datopotamab deruxtecan for advanced EGFR-mutated NSCLC, offering new hope for previously treated ...

“This is a historic day in the decades-long fight against HIV,” Gilead CEO Daniel O’Day said in the company’s announcement.

The labeling, or prescribing information, is thus subject to FDA regulations and is a requirement for all approved drug and biological drug products. A label contains information necessary for ...

Vivasure Medical announced today that it submitted its PerQSeal Elite vascular closure system to the FDA for premarket ...

FDA Approves Yeztugo as First Twice-Yearly Injectable HIV Prevention Option in the U.S. Clinical Trials Show Near-Perfect ...