FDA News Highlights AJPB Week in Review

5. Antipsychotic Drug Linked to Deaths in Parkinson's Patients

Reported deaths of Parkinson's patients treated with Acadia Pharmaceutical’s antipsychotic therapy pimavanserin (Nuplazid) has sparked concern. Read more.

4. FDA Restricts Sale of Bayer Permanent Contraception Device

FDA to limit distribution of Bayer’s Essure device to guarantee women considering permanent contraception are provided with adequate risk information. Read more.

3. FDA Approves Expanded Indications for Exparel

Bupivacaine liposome injectable suspension (Exparel) is the first long-acting, single-dose nerve block for patients undergoing upper extremity surgeries. Read more.

2. Acute Migraine Treatment Shows Positive Results in Trials

An acute treatment for migraines achieved both co-primary regulatory endpoints in 2 pivotal phase 3 trials. Read more.

1. FDA OKs Marketing for First AI Device for Diabetic Retinopathy Detection

Officials with the FDA have approved marketing of the first medical device to use artificial intelligence (AI) to detect notable eye disease diabetic retinopathy (DR) in adults with diabetes. Read more.