The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

: FDA intends to finalize compliance policy that would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes, clearing the market these products.

FDA approves Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.

FDA recommends duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety.

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

A new study in the American Journal of Preventive Medicine highlights the continued success and impact the FDA’s “The Real Cost” campaign has had on youth smoking initiation.

The FDA approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

The FDA is warning consumers not to purchase or drink Miracle Mineral Solution, a product sold online as a medical treatment due to a recent rise in reported health issues.

FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery.

FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis

FDA approves treatment for adult patients with certain types of myelofibrosis.

FDA approves third cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated

FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis of the lungs.

Statement by Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy

FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

FDA suspends facility registration of Texas-based seafood producer

FDA is launching its first youth e-cigarette prevention TV ads and is planning to provide new educational resources as agency approaches one-year anniversary of public education campaign.

A federal court ordered an Arkansas company to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.

FDA expanded the indication for Symdeko for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.