Vepdegestrant (Veppanu – Rigel), an oral heterobifunctional protein degrader, has been approved by the FDA for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer in adults who had disease progression following ≥1 prior line of endocrine therapy. It is the first proteolysis targeting chimera (PROTAC), a type of heterobifunctional protein degrader, to be approved in the US. The oral selective estrogen receptor degraders (SERDs) elacestrant (Orserdu) and...

The FDA has licensed mFLUSIVA (Moderna), the first mRNA-based influenza vaccine in the US, for prevention of influenza in adults ≥50 years old. mFLUSIVA will be available for the 2026-2027 influenza season. Three mRNA COVID-19 vaccines (Comirnaty, Spikevax, and mNEXSPIKE) and one mRNA RSV vaccine (mRESVIA) are also licensed in the US.

Proton pump inhibitors (PPIs), which are used for treatment of gastroesophageal reflux disease (GERD) and for prevention of upper gastrointestinal adverse effects caused by NSAIDs and aspirin, are one of the most commonly prescribed classes of drugs in the US. All PPIs are similarly effective and generally well tolerated, but their long-term use has been associated with a number of safety concerns. Recommendations addressing these concerns have recently been published.

The FDA has approved baloxavir marboxil (Xofluza – Shionogi/Genentech), the first polymerase acidic (PA) endonuclease inhibitor, for single-dose, oral treatment of acute uncomplicated influenza in patients ≥12 years old. Baloxavir is the first drug with a new mechanism of action to be approved for treatment of influenza in almost 20 years.

In 2012, the FDA required manufacturers of HMG-CoA reductase inhibitors (statins) to add a warning to their labels about reports of increased blood glucose and glycosylated hemoglobin (HbA1c) levels. Since then, several new studies have been published.

The FDA has approved Eloctate (Biogen), a recombinant factor VIII Fc fusion protein with an extended half-life, for use in adults and children with hemophilia A. Eloctate is indicated for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It is the first antihemophilic factor VIII Fc fusion protein to be approved for hemophilia A.

The FDA has approved ferric citrate (Auryxia – Keryx), an oral phosphate binder, for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. It is the second iron-based phosphate binder to be approved in the US, and the first that causes significant systemic absorption of iron. Auryxia is not FDA-approved for treatment of iron deficiency anemia.

The FDA has approved eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist and delta-opioid receptor antagonist, for oral treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).

The FDA has approved Xtampza ER (Collegium), a new extended-release, abuse-deterrent capsule formulation of oxycodone, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Two new extended-release amphetamine products have been approved by the FDA for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old: Adzenys XR-ODT (Neos Therapeutics), an orally distintegrating tablet, and Dyanavel XR (Tris Pharma), an oral suspension.