FDA News

Novel Drug for Metastatic Prostate Cancer Approved

Radium-223, a first-in-class drug, travels directly to the site of bone metastases, where it emits alpha particles that exert an anti-tumor effect.

FDA Announces New Interactive Patient Network

FDA Announces New Interactive Patient Network

Interactive tool designed to educate patients and advocates about processes of drug development.

First-in-Class Diabetes Drug Approved

Canagliflozin blocks reabsorption of glucose in the kidney, increases glucose excretion, and lowers blood glucose levels.

FDA: Omontys Injection Pulled From Market

FDA: Omontys Injection Pulled From Market

Voluntary recall of anemia drug due to reports of anaphylaxis, including three deaths

FDA Approves 1st OTC Drug for Women With Overactive Bladder

FDA Approves 1st OTC Drug for Women With Overactive Bladder

Oxytrol is intended for use by those 18 and older.

FDA Warns About Tolvaptan-Related Liver Injury

In clinical trials, three patients treated with the hyponatremia drug experienced liver injury, which improved after discontinuing treatment.

Abiraterone Use Expanded for Advanced Prostate Cancer

Abiraterone Use Expanded for Advanced Prostate Cancer

Decreases body's production of testosterone.

FDA Clears Insulin Pump Therapy Device

The FDA has approved the Accu-Chek Combo system, a combination blood glucose meter and insulin pump that exchanges data using Bluetooth technology.

Long-Acting Drug for Post-Op Pain Approved

The FDA has approved Exparel (bupivacaine), a single-dose injection that provides post-surgical pain relief for up to 72 hours.

Drug Cleared for Treating ADT-Related Bone Loss in Prostate Cancer Patients

The FDA has approved denosumab (Prolia) as a treatment to increase bone mass in prostate cancer patients at high risk for fracture undergoing androgen deprivation therapy (ADT) and women with breast cancer at high risk for fracture who are receiving aromatase inhibitor therapy.

New Indication Okayed for Chronic Hepatitis B Drug

Bristol-Myers Squibb of Princeton, N.J., has received FDA approval to market Baraclude (entecavir) as a treatment for chronic hepatitis B (CHB) patients with evidence of decompensated liver disease.

New Oral Anticoagulant Cleared for Reducing Stroke Risk

Pradaxa (dabigatran etexilate) capsules have received FDA approval for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).

FDA Takes On Unapproved Single-Ingredient Colchicine

The FDA has ordered a halt to the marketing of unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of familial Mediterranean fever.

Withdrawal of Approval for Midodrine Proposed

The FDA has proposed withdrawing approval of midodrine, a drug used to treat orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the medication have not been done, the agency announced.

Drug for Chronic Refractory Gout Approved

Savient Pharmaceuticals, Inc., of East Brunswick, N.J., has received FDA clearance to market Krystexxa (pegloticase) as a treatment for chronic gout in adult patients refractory to conventional treatment.