FDA Expands Tremfya Label to Highlight Protection Against Joint Damage in Psoriatic Arthritis

Tremfya is a prescription biologic medicine used as an intravenous injection or under-the-skin shot for treating certain immune-related inflammatory diseases. The FDA has approved an update to its label to include evidence that Tremfya can… Read more

Afrezza: FDA Clears Use for Children 6 and Older With Type 1 or Type 2 Diabetes

Afrezza is a fast-acting insulin that you breathe in as you start a meal. It lowers blood sugar by helping your muscles and fat use sugar and by telling your liver to make less sugar.… Read more

Enhertu: FDA Clears New Pre- and Post-Surgery Uses in HER2-Positive Early Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is a prescription intravenous (IV) targeted cancer treatment called an antibody-drug conjugate. The FDA has approved it for two uses in adults with HER2-positive early-stage breast cancer. It can now be used… Read more

Zaynich: FDA Approves New IV Antibiotic for Complicated Urinary Tract Infections in Adults

Zaynich (cefepime and zidebactam) is an intravenous (IV) antibiotic that is FDA-approved for adults with complicated urinary tract infections (cUTIs) that are caused by certain Gram-negative bacteria. Unlike a typical UTI, a cUTI usually affects… Read more

FDA Approves Lipfendra, the First Daily Pill of Its Kind to Lower Bad Cholesterol

Lipfendra (enlicitide) is a new prescription medicine approved by the FDA. It is used along with a healthy diet and exercise to help lower bad cholesterol in adults. This includes adults who have an inherited… Read more

FDA Approves Lytenava Eye Injection for Wet Age-Related Macular Degeneration

Lytenava (bevacizumab) is now FDA approved to treat adults with neovascular age-related macular degeneration, which is also called wet AMD. Wet AMD is an eye disease that affects the center of your vision. It can… Read more

FDA Approves Simtriyo, a New Type of Stimulant, for Adults and Children With ADHD

The FDA has approved Simtriyo (centanafadine) to treat attention deficit hyperactivity disorder, also known as ADHD. It is approved for adults, as well as children who are 6 years of age and older and weigh… Read more

Headline: FDA Approves Gwyn Lo, a New Low-Dose Weekly Birth Control Patch

The FDA has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system). It is a new birth control skin patch for women who can get pregnant and have a body mass index (BMI) under 30.… Read more

FDA Approves mFlusiva, the First mRNA Flu Vaccine for Older Adults

The FDA approved mFlusiva to help prevent the flu in adults ages 50 and older. The flu is a viral infection that affects the lungs and breathing airways. It causes a fever, body aches, and… Read more

FDA Approves Tudriqev for Advanced Skin Cancer

The FDA has approved Tudriqev (vusolimogene oderparepvec-wtpg) to treat adults with advanced skin cancer called cutaneous melanoma. It is used for cancer that cannot be removed by surgery and has gotten worse after treatment with… Read more