FDA Updates

Annie Lambert, PharmD, BCSCP, discusses the key approaches to ensuring safe and effective dispensing of compounded GLP-1 medications.

This landmark decision follows previous approvals for adults 60 years and older, as well as those aged 50 to 59 years at increased risk.

FDA approves Wellcovorin for rare FOLR1 cerebral folate deficiency, spotlighting real-world evidence, dosing goals, and key drug-interaction risks.

The FDA approves Sotyktu, the first selective TYK2 oral pill for active psoriatic arthritis, improving joints and skin with key safety monitoring.

FDA targets telehealth ads for compounded glucagon-like peptide-1s, warning of misleading claims, hidden sources, and safety risks amid social media hype.

FDA expands lomitapide use to children 2 years and older, highlighting major low-density lipoprotein reductions.

The FDA expands the drug's usage to treat idiopathic short stature, small for gestational age, and growth failure associated with Noonan syndrome.

Upon approval, dupilumab becomes the first and only medication on the market to target adult and pediatric patients’ allergic fungal rhinosinusitis.

The FDA approves Bysanti (milsaperidone) for schizophrenia and bipolar I disorder, leveraging iloperidone bioequivalence, with key metabolic monitoring needs.

In a move that comes as a surprise to Moderna and various vaccine experts, the FDA continues its skeptic exploration of mRNA vaccine technology.

IBSA’s formulation of sildenafil, known as Vybrique, will hit the market in March 2026 as the first and only oral film that treats erectile dysfunction.

This marks the disease’s very first treatment option for pediatric patients looking to manage Menkes and its symptoms.

The administration announces back-to-back approvals for oral therapies used to treat uncomplicated urogenital gonorrhea.

FDA approves denosumab biosimilars Boncresa and Oziltus, enhancing access to affordable treatments for osteoporosis and oncology-related conditions.

FDA approves tradipitant, a treatment for motion sickness, offering effective prevention after 40 years without new options.

The top women's health stories in 2025 included groundbreaking advancements in women's health against an alarming mortality trend.

In this episode, Natalie DiPietro Mager, PharmD, PhD, MPH, meets with Karen Kier, PhD, RPh, BCPS, BCACP, to discuss warning labels for hormonal replacement therapy.

The FDA expands Addyi's approval, offering hope for women under 65 with low sexual desire, marking a significant advancement in women's sexual health.

FDA approves etripamil nasal spray, offering a rapid, self-administered solution for adults with paroxysmal supraventricular tachycardia (PSVT).

The agency’s findings spur promises of significant change to the development and recommendations surrounding various immunizations.

Regeneron Pharmaceuticals’ newest drug will be the first and only approved flexible treatment option for retinal vein occlusion.

The FDA approves denosumab biosimilars Osvyrti and Jubereq, expanding treatment options for osteoporosis and bone-related conditions.

FDA approves lumateperone as an adjunct therapy for major depressive disorder, offering new treatment options for this indication.

The FDA releases its updated recommendations and scientific considerations for the demonstration of safety and efficacy among biosimilars and their reference products.

The approval includes a single and once monthly maintenance injection compared with 2 100 mg/1 mL injections.

Tezspire gains FDA approval as the first biologic for chronic rhinosinusitis with nasal polyps, offering improved patient outcomes.

FDA approves oral semaglutide for reducing cardiovascular risks in high-risk type 2 diabetes patients, enhancing treatment options and outcomes.

The FDA expands Yuflyma's approval to treat hidradenitis suppurativa and uveitis in pediatric patients, enhancing treatment options for chronic conditions.