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

Tecentriq and Tecentriq Hybreza: FDA Approves First ctDNA‑Guided Adjuvant Immunotherapies to Target Residual Muscle‑Invasive Bladder Cancer After Surgery

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription immunotherapy medicines used to help the body’s immune system fight cancer. The FDA has now approved them to treat muscle-invasive bladder cancer (MIBC) in adults after… 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

Beqalzi: FDA Approves New Oral BCL-2 Blocker for Relapsed or Refractory Mantle Cell Lymphoma

Beqalzi (sonrotoclax) is a prescription, targeted, oral cancer medicine that has received accelerated FDA approval for treating adults with mantle cell lymphoma (MCL) that has relapsed or become resistant after at least two prior treatments,… 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

Inqovi: FDA Approves First All‑Oral Regimen for Certain Patients With Newly Diagnosed Acute Myeloid Leukemia

Inqovi is a fixed‑dose oral pill that contains two medicines, decitabine and cedazuridine. The FDA has approved using Inqovi along with another oral pill, venetoclax, for treating newly diagnosed acute myeloid leukemia (AML) in adults… Read more

Xocova: FDA Approves First Oral Post-Exposure Prophylaxis to Help Prevent COVID-19 in Adults and Adolescents 12 and Older

Xocova (ensitrelvir) is a prescription antiviral medicine you take by mouth to lower your chance of getting COVID-19 after you have been in close contact with someone who has the virus. It is approved for… 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

Cavhanza (Nilotinib): FDA Approves Orally Disintegrating Tablet for Adults With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Cavhanza (nilotinib) is a new FDA-approved orally disintegrating tablet (ODT) formulation of nilotinib, a prescription medicine used to treat a type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). The FDA has… Read more

Hympavzi: Once‑Weekly, Single‑Dose Under‑the‑Skin Shot to Help Prevent Bleeding in Hemophilia A or B (ages 6+)

Hympavzi (marstacimab‑hncq) is a preventive medicine you take as a once‑weekly shot under the skin. It is used in adults and in children 6 and older with hemophilia A or hemophilia B, whether or not… Read more