Elahere was found to improve survival in patients with FR-alpha–positive, platinum-resistant, high-grade serous epithelial ...

Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen that ...

Elahere (mirvetuximab soravtansine) was approved by the FDA for the treatment of platinum-resistant ovarian cancer. In the trial that supported its approval, approximately 30% of patients responded to ...

The US Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss ...

Tecentriq Hybreza, a subcutaneous delivery of the drug, was approved for certain types of sarcoma, in addition to lung, skin and liver cancers. The Food and Drug Administration (FDA) approved ...

More than half (60%) of patients in latest trial reached active remission and 41% stopped taking corticosteroid entirely.

The FDA approved the software device, “Hearing Aid Feature,” which the agency said could be installed on Apple’s AirPods Pro headphones to amplify sounds for anyone 18 or older with mild to ...

Sponsor Message The FDA approval came after a clinical study with 118 subjects with perceived mild to moderate hearing loss. The results showed that the subjects who used Apple's hearing aid ...

Apple has received Federal Drug Association (FDA) approval for a new Watch feature it says can detect signs of sleep apnea. The tool, available in several Watch models starting this week ...

While the feature was announced, Apple couldn't bring it to the Apple Watch until the FDA approved it. A 510(k) Premarket Notification in a medical device database updated on Monday reveals the ...

The FDA on Thursday said its marketing authorization of the product was its first ever for a over-the-counter hearing aid software device. Related Apple to release AirPods with built-in hearing ...