Elahere suffered multiple development setbacks, including a failed Phase III study, but was ultimately granted accelerated approved by the FDA in ovarian ... making 17. The history of ADCs is ...

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

ImmunoGen, Inc. has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. This first FDA antibody-drug ...

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 ...

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

The FDA approved ribociclib (Kisqali) for adjuvant treatment of high-risk, hormone receptor-positive, HER2-negative early breast cancer. The FDA approved ribociclib (Kisqali) with an aromatase ...

Withings has offered sleep apnea detection in devices for some time, while Samsung received FDA approval for its Galaxy Watch line earlier this. The feature arrives as another — blood oxygen ...

Kisqali has been FDA-approved with an aromatase inhibitor as postsurgical treatment for some with early breast cancer at a high risk of recurrence. The Food and Drug Administration (FDA) has approved ...

According to the FDA's approval notice, the Apple Watch sleep apnea function is not a diagnostic tool, but rather an over-the-counter device designed to assess watch-wearers' risk of sleep apnea.

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 ...

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 ...

After getting FDA approval for hearing aid detection on AirPods Pro 2 last week, the US Food and Drug Administration gave Apple a green light (via TechCrunch) for sleep apnea detection Apple Watch ...