Drug Approvals

BEQVEZ™ (fidanacogene elaparvovec-dzkt): A New FDA-Approved Gene Therapy for Hemophilia B

BEQVEZ™ (fidanacogene elaparvovec-dzkt): A New FDA-Approved Gene Therapy for Hemophilia B

Jun 9, 2026

BEQVEZ is prescribed for adults with moderate to severe hemophilia B, a rare inherited bleeding disorder caused by low levels of clotting factor IX. People with hemophilia B can experience serious bleeding episodes, including bleeding into joints, muscles, and internal organs. Many patients require regular factor IX infusions throughout their lives to prevent dangerous bleeding. BEQVEZ is important because it is a one-time gene therapy designed to help the body produce its own factor IX instead of relying on ongoing replacement therapy. This treatment offers a new long-term approach for eligible patients with hemophilia B. The FDA approved BEQVEZ on May 13, 2026.

IDVYNSO™ (doravirine and islatravir): A New FDA-Approved Two-Drug HIV Treatment Simplifying Long-Term Care

IDVYNSO™ (doravirine and islatravir): A New FDA-Approved Two-Drug HIV Treatment Simplifying Long-Term Care

Jun 7, 2026

IDVYNSO is prescribed for adults with HIV-1 infection who are already virologically suppressed on a stable antiretroviral regimen. This means their HIV viral load is already controlled at very low levels before switching to IDVYNSO. HIV is a lifelong viral infection that attacks the immune system and requires continuous treatment to prevent progression to AIDS and other complications. Many patients remain on treatment for decades, so newer therapies that reduce pill burden and simplify care are important. IDVYNSO offers a complete two-drug treatment option that may help certain patients maintain viral suppression with fewer antiretroviral medicines. The FDA approved IDVYNSO on April 20, 2026.

AWIQLI® (insulin icodec): The First Once-Weekly Insulin Approved for Diabetes Management

AWIQLI® (insulin icodec): The First Once-Weekly Insulin Approved for Diabetes Management

Jun 4, 2026

What is it prescribed for? AWIQLI is prescribed for adults with diabetes mellitus who need long-acting insulin to help control blood sugar levels. Diabetes is a chronic condition in which the body cannot properly regulate glucose, leading to high blood sugar that can damage the heart, kidneys, eyes, and nerves over time. Many people with diabetes require daily...

BYSANTI™ (milsaperidone): A New FDA-Approved Treatment Offering Hope for Schizophrenia and Bipolar I Disorder

BYSANTI™ (milsaperidone): A New FDA-Approved Treatment Offering Hope for Schizophrenia and Bipolar I Disorder

May 1, 2026

What is it prescribed for? Bysant ™ is a newly approved medication for treating schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. These serious mental health conditions can deeply affect a person’s thoughts, emotions, and ability to function. Schizophrenia can cause hallucinations, delusions,...

DATROWAY: FDA Approves New Treatment for HR-Positive, HER2-Negative Breast Cancer

DATROWAY: FDA Approves New Treatment for HR-Positive, HER2-Negative Breast Cancer

Apr 13, 2026

What is it prescribed for? DATROWAY™ is used to treat adults with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have already received endocrine-based therapy and chemotherapy​. Datroway was Approved by the FDA on January 17 2025 What is the name of the drug and what does it do?...