FDA Updates

The FDA expands Auvelity for Alzheimer-related agitation, offering a first nonantipsychotic option backed by trials.

FDA approves Caplyta to prevent schizophrenia relapse, cutting risk 63% with a stable metabolic profile.

The adeno-associated virus (AAV) vector-based gene therapy lunsotogene parvec-cwha received approval through the FDA Commissioner’s National Priority Voucher pilot program.

The drug’s indication for uncontrolled chronic spontaneous urticaria is the first biologic medicine of its kind, specifically explored amongst children 2 to 11 years old.

GSK’s investigational drug for liver treatment was given fast-track designations to improve access in what the FDA considers a significant unmet medical need.

FDA expands Tzield use to age 1 year to delay stage 3 type 1 diabetes, enabling earlier immune intervention.

FDA approves Idvynso, a 2-drug HIV switch option for suppressed adults, supporting simpler care as people age with HIV and manage multiple conditions.

In a recent research letter, investigators establish how removal of in-person dispensing requirements impact mifepristone pharmacy access.

Matt Sample and Neal Cooper join to discuss the beginning stages of the FDA’s 7-year rollout of new NDCs for prescription drugs.

Orforglipron is the first new molecular entity to be cleared under the FDA Commissioner's National Priority Voucher pilot program.

The biosimilar is approved for all indications of the reference product, including the treatment of postmenopausal women with osteoporosis at high risk for fracture.

The FDA approves removing the age requirement for epinephrine nasal spray (neffy) 1 mg, effectively allowing all children and adults who weigh 33 pounds.

Awiqli represents a significant shift in the treatment landscape, potentially reducing the burden of basal insulin administration from 365 injections a year to 52.

The FDA clears the highest-dose weekly semaglutide for obesity, showing 20.7% mean weight loss with the same blood sugar-lowering effects.

MiniMed Flex is a smaller, screenless, and phone-controlled insulin automation that shows how pharmacists boost AID success for patients with diabetes.

FDA approves icotrokinra as a first-line systemic treatment of plaque psoriasis with a targeted oral peptide for adults and pediatric patients.

The FDA clears secukinumab for patients 12 years and older with tough hidradenitis suppurativa, offering weight-based IL‑17A biologic relief and new guidance on screening and safety.

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 reversal of its refusal-to-file letter issued last week, the FDA decides to move forward with Moderna’s mRNA flu vaccine developments.

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