2025 FDA Drug Approvals

• A new option for hard-to-control asthma: The FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for people with severe asthma.

• Designed to reduce flare-ups: The injectable biologic targets inflammation linked to asthma attacks and is meant to be used alongside standard inhaled therapies.

• Not a rescue medicine: Exdensur is for long-term control, not for sudden asthma symptoms.

For consumers living with severe asthma that remains difficult to control, a newly approved medication may offer another layer of protection. The U.S. Food and Drug Administration has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for adults with severe asthma.

Severe asthma affects a smaller but significant group of patients whose symptoms persist despite regular use of inhaled corticosteroids and other long-acting asthma medicines. These patients often experience frequent flare-ups that can lead to emergency room visits, hospitalizations, or missed work and school.

Exdensur belongs to a class of drugs known as biologics, which are made from living cells and are designed to target specific parts of the immune system. The medication works by blocking interleukin-5 (IL-5), a protein involved in the production and survival of eosinophils, white blood cells that contribute to airway inflammation in certain types of asthma.

By reducing this inflammation, Exdensur aims to lower the risk of asthma attacks over time.

What patients should know

Exdensur is not a replacement for daily inhalers and is not intended for sudden breathing emergencies. Instead, it is used regularly as an add-on therapy to help keep asthma under better control.

Key points for patients include:

• Administration: Exdensur is given by injection, typically at scheduled intervals determined by a healthcare provider.

• Who it’s for: It is intended for people with severe asthma whose disease is not well controlled with standard treatments.

• Expected benefits: Clinical studies showed fewer asthma exacerbations in patients receiving the drug in addition to their usual medications.

Possible side effects

As with other biologic asthma treatments, side effects may include injection-site reactions, headache, or fatigue. Because Exdensur affects the immune system, patients should discuss their full medical history with their doctor to understand potential risks and benefits.

Patients with severe asthma should not change or stop medications on their own. If asthma symptoms remain poorly controlled despite following a treatment plan, a healthcare provider can determine whether a biologic therapy like Exdensur is appropriate.

The approval of Exdensur adds to a growing list of targeted asthma treatments, giving patients and doctors more options to personalize care and reduce the burden of this chronic disease.

• FDA approves Keytruda Qlex, a subcutaneous injection version of the widely used cancer therapy Keytruda

• Patients can now receive treatment in as little as one to two minutes, compared to a 30-minute IV infusion

• New option offers greater convenience and flexibility in treatment settings, from hospitals to local clinics

The U.S. Food and Drug Administration (FDA) has approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a new subcutaneous form of Merck’s flagship cancer immunotherapy Keytruda. This marks the first time patients across most of Keytruda’s 38 cancer indications will have access to the drug in an injection form rather than an intravenous (IV) infusion.

Keytruda Qlex can be administered by a healthcare provider in just one minute every three weeks or two minutes every six weeks. That’s a major time savings compared to the 30-minute IV infusion required for traditional Keytruda.

“This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers,” said Dr. J. Thaddeus Beck, oncologist and medical director of the Highlands’ Clinical Trials Office. “Subcutaneous pembrolizumab provides faster administration, two dosing options, and more choices for where patients can receive care.”

Comparable effectiveness and safety

In pivotal clinical trials, Keytruda Qlex showed similar effectiveness and safety compared to IV Keytruda. Patients with advanced lung cancer who received the injection saw response rates and survival outcomes nearly identical to those receiving the infusion.

The new formulation was developed with the help of biotechnology company Alteogen Inc., whose enzyme allows pembrolizumab to be delivered under the skin instead of through a vein.

For patients who struggle with vein access or who don’t have a port in place, the subcutaneous injection may simplify treatment. It also gives patients and providers more flexibility in choosing where treatment takes place, whether in a hospital infusion center, a doctor’s office, or a community clinic.

“This is about giving patients options and helping them manage treatment in a way that best fits their needs,” said Dr. Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories.

Safety considerations

As with IV Keytruda, Keytruda Qlex carries risks of serious immune-related side effects, which may affect organs such as the lungs, liver, or kidneys, and in rare cases can be life-threatening. 

It is not recommended for certain patients, including those with hypersensitivity to its components or pregnant women due to potential risks to the fetus. Patients are encouraged to discuss the benefits and risks with their healthcare team.

Merck expects Keytruda Qlex to be available in the United States in late September. Patients and caregivers can ask their oncologists if the new injection option is right for them.

Johnson & Johnson has announced that the U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder who have not responded adequately to at least two oral antidepressants. 

The company hailed the approval as “a significant advancement in the treatment of MDD,” a condition affecting approximately 21 million adults in the United States.

Major depressive disorder is one of the most prevalent psychiatric disorders, and about one-third of patients do not respond to traditional oral antidepressants, severely impacting the quality of life and contributing to the high economic burden associated with treatment-resistant depression.

Image below via Johnson & Johnson

Complicated treatment

"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” said Bill Martin, head of Neuroscience at Johnson & Johnson Innovative Medicine.  

“Spravato is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral antidepressants."

The FDA's decision followed a priority review and was based on positive outcomes from a randomized, double-blind, placebo-controlled study.

Johnson & Johnson said the study demonstrated that Spravato significantly improved depressive symptoms compared to placebo, with 22.5% of patients achieving remission at week four, compared to 7.6% in the placebo group. The safety profile of SPRAVATO® was consistent with previous data, with no new safety concerns identified.

The new drug is available only through a restricted program known as the Spravato Risk Evaluation and Mitigation Strategy Program.