The HCPFive: Top News for Healthcare Providers from the Week of 04/26

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) approvals of anifrolumab-fnia (Saphnelo) for subcutaneous self-administration in systemic lupus erythematosus (SLE) and lumateperone (Caplyta) for schizophrenia, clearance of Tandem Diabetes Care’s Control-IQ+ automated insulin delivery technology for use during pregnancy complicated by type 1 diabetes, Priority Review and Breakthrough Therapy Designation for bepirovirsen in chronic hepatitis B, and approval of AstraZeneza’s budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler triple-combination maintenance therapy for asthma in adult and pediatric patients 12 years of age and older.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of April 26, 2026—let’s jump in!

Anifrolumab (Saphnelo) Wins FDA Approval for Subcutaneous Self-Administration in SLE

On April 27, 2026, the FDA approved anifrolumab-fnia (Saphnelo) for subcutaneous self-administration via a once-weekly 120 mg autoinjector, the Saphnelo Pen, for adult patients with moderate to severe SLE receiving standard therapy. The decision was based on results from the phase 3 TULIP-SC trial.

Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

On April 26, 2026, the FDA approved a supplemental New Drug Application (sNDA) for lumateperone (Caplyta) based on long-term data supporting the prevention of relapse in adults with schizophrenia. Specifically, a phase 3 randomized withdrawal trial demonstrating a 63% reduction in relapse risk versus placebo over a 26-week double-blind treatment period.

FDA Clears Control-IQ+ for Use in Pregnancy With Type 1 Diabetes

On April 27, 2026, the FDA cleared Tandem Diabetes Care’s Control-IQ+ automated insulin delivery technology for use during pregnancy complicated by type 1 diabetes, expanding the label for the company’s t:slim X2 and Tandem Mobi systems. According to the Company, this makes Control-IQ+ the first commercially available automated insulin delivery system in the US with a pregnancy indication.

FDA Grants Bepirovirsen Breakthrough Therapy Designation, Priority Review for Chronic Hepatitis B

On April 28, 2026, the FDA accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide developed by GSK in partnership with Ionis Pharmaceuticals, for the treatment of adults with chronic hepatitis B. The Agency simultaneously granted bepirovirsen Breakthrough Therapy designation and established a PDUFA target action date of October 26, 2026.

If approved, bepirovirsen would represent the first therapy to achieve clinically meaningful functional cure rates in this population, addressing a significant gap in the current treatment landscape.

FDA Approves BGF Triple Therapy for Asthma in Patients 12 and Older

On April 28, 2026, the FDA approved AstraZeneza’s budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler triple-combination maintenance therapy for asthma in adult and pediatric patients 12 years of age and older. The decision marks the second approved indication for BGF, which received FDA clearance for chronic obstructive pulmonary disease in adults in 2020.