Triple Combination Hypertension Pill Approved

On June 9, 2025, the US Food and Drug Administration (FDA) approved George Medicines’ Widaplik^™ (telmisartan, amlodipine, indapamide) for the treatment of hypertension in adults, including as initial treatment. This is the first single pill triple combination therapy including low doses of the angiotensin II receptor blocker (ARB) telmisartan, calcium channel blocker (CCB) amlodipine and diuretic indapamide. The approval is based on positive results from two phase III trials showing significant improvement in blood pressure control compared to placebo and dual combinations. Blood pressure medications are only modestly effective at reducing blood pressure, even at high doses, and most patients will require two or more medicines to achieve control. The recommended dose for initial treatment is telmisartan 10mg, amlodipine 1.25mg and indapamide 0.625mg (10mg/1.25mg/0.625mg) or 20mg/2.5mg/1.25mg orally once daily. The dose should be titrated up to a maximum dose of 40mg/5mg/2.5mg. Launch is expected in quarter four of 2025. Full prescribing information is available here.

Meloxicam Injection Approved for Pain

On June 10, 2025, the FDA approved Azurity Pharmaceutical’s Xifyrm^™ (meloxicam injection) for use in adults for the management of moderate-to-severe pain, alone or in combination with non-steroidal anti-inflammatory drug (NSAID) analgesics. An NSAID analgesic, Xifyrm is given as an intravenous (IV) bolus injection over 15 seconds once daily. Xifyrm has a delayed onset of action and therefore should not be recommended alone when immediate analgesia is required. NSAIDs, including Xifyrm, should be taken only long enough for pain to resolve. Using them has been associated with increased risks of gastrointestinal (GI) damage, heart attacks and strokes. The launch is expected in the coming weeks. Here is the prescribing information.

Mavyret Approval Extended to Acute Hepatitis C 

The FDA expanded AbbVie’s Mavyret^® (glecaprevir 300mg/pibrentasvir 120mg) approval to include the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis on June 11, 2025. Previously, the indication only included chronic disease. This approval allows treatment with the eight-week dosing regimen of Mavyret at the time of HCV diagnosis and holds a 96% cure rate. Some patients still will need 12 weeks or 16 weeks of therapy, however. The recommended dose is three tablets taken together once every day. Mavyret is a fixed-dose combination of glecaprevir, an HCV NS3/4A protease inhibitor and pibrentasvir, an HCV NS5A

Inhibitor. Labeling includes a boxed warning that taking Mavyret can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be tested for HBV before treatment begins and then monitored for signs of infection with it during and for several months after treatment ends. For Mavyret’s full prescribing information, look here.

New Tablet Formulation of Brukinsa to Replace Capsules

BeOne Medicine’s Brukinsa^® (zanubrutinib) tablets were approved on June 11, 2025, for all five approved indications that the capsule currently holds, including chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia, mantle cell lymphoma, relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. The newly approved tablets are 160mg each, allowing a dose of two tablets rather than four of the current 80mg capsules for the recommended dose of 320mg daily. The tablets will replace the capsule formulation starting in October 2025. Full prescribing information may be found here.

FDA Expands Approval of Moderna’s RSV Vaccine, mRESVIA

On June 12, 2025, the FDA approved Moderna’s mRESVIA^® (respiratory syncytial virus vaccine, mRNA-1345) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 18-59 years with increased risk due to chronic conditions such as chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease and diabetes. This expands the previous approval for adults aged 60 years and older. Moderna estimated that over one-third of adults aged 18-59 years have at least one underlying condition that puts them at risk of severe RSV. Supported by phase III study results showing strong immunogenicity and safety, mRESVIA met non-inferiority criteria compared to older adults. The vaccine was well-tolerated, with common adverse reactions including injection site pain, fatigue and headache. Two other RSV vaccines have been approved for use in the US market, including Pfizer’s Abrysvo^® and GSK’s Arexvy^®.Both are indicated for use in patients 60 years of age and older and adults aged 18-59 years with increased risk due to chronic conditions. Abrysvo is also approved for vaccinating women who are in late pregnancy to help protect newborns from LRTD caused by RSV during the first six months of life. While FDA approval is crucial, the Center for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) must recommend the shots before they are available for 18-59 age group. Currently ACIP recommends the vaccine for adults aged 75 years and older, and adults aged 60 to 74 years at increased risk of infection. Moderna plans to have mRESVIA available for the 2025-2026 season. Full prescribing information is available here.

Keytruda Gets Approval for Head and Neck Cancers

The FDA granted another approval to Keytruda^® (pembrolizumab – Merck) on June 12, 2025, for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent. This approval, the first in six years for HNSCC and the only perioperative treatment approach in HNSCC, is based on the KEYNOTE-689 trial, showing a 30% reduction in event-free survival (EFS) compared to standard of care. Keytruda has numerous other FDA approvals with and without other cancer drugs for treating various types of endometrial cancer, non-small cell lung cancer (NSCLC), some kidney cancers, some esophageal, stomach and head and neck cancers, as well as Merkel cell carcinoma, multiple myeloma and non-Hodgkin lymphoma. It also has indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers) rather than developing from a particular body tissue. For most of its indications, including the newly extended one, the recommended dose is 200mg once every three weeks or 400mg once every six weeks administered as a 30-minute IV infusion. Here is the updated prescribing information.

Issues Document Available: Navigating the Diverging Paths of COVID-19 Vaccine Recommendations

The recent policy shifts by the FDA and the Centers for Disease Control and Prevention (CDC) regarding coronavirus disease 2019 (COVID-19) vaccines have sparked confusion. The FDA’s new requirement for placebo-controlled clinical trials before approving vaccines for healthy individuals under 65 years of age contrasts with the CDC’s more flexible approach, allowing vaccines for children and pregnant women through shared decision-making with their providers. This document explores the implications of these differing stances, their potential impact on public health, and the ongoing debates among experts and policymakers. The Issues Document is attached.