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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.

Could GLP-1 Medicines Help Lower Breast Cancer Risk? 

Could GLP-1 Medicines Help Lower Breast Cancer Risk? 

Jun 9, 2026

GLP-1 medicines are best known for treating type 2 diabetes and helping with weight loss. Now, researchers are studying whether these medications may have other health effects, including a possible link to lower breast cancer risk. A new study looked at women who had breast imaging and found that those prescribed GLP-1 medicines had a lower rate of breast cancer...

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...

Investigational Pancreatic Cancer Drug Receives Expanded Access From the FDA

Investigational Pancreatic Cancer Drug Receives Expanded Access From the FDA

Jun 3, 2026

The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.

FDA regulations allow expanded access to investigational drugs for treatment purposes for larger populations under a treatment protocol or treatment investigational new drug application. Per EAP guidelines, requests for expanded access must be submitted to the sponsor by physicians licensed in the U.S. on behalf of eligible patients.

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List

Jun 1, 2026

The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing.Â