Istituzioni

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

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

Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, Australia and Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

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 has issued a proposed rule to require new health warnings on cigarette packages and in ads to promote greater public understanding of the negative health consequences of smoking.

The FDA posted a warning letter for significant current good manufacturing practice violations, including data integrity issues.

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

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

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

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 has issued a warning letter to Curaleaf Inc. for illegally selling unapproved cannabidiol products online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.

FDA approves first therapy for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)