FDA Updates

Pharmacists help women choose safer hormone replacement therapy or nonhormonal relief options.

The approval arrives prior to the Prescription Drug User Fee Act action date of June 16, 2026.

This regulatory milestone establishes inhaled insulin as the first and only noninjectable mealtime insulin option for children and adolescents.

FDA updates Tremfya label in psoriatic arthritis, confirming it slows structural joint damage and helping patients protect mobility while easing symptoms.

New FDA label lets linaclotide treat functional constipation in children 2 to 5, with dosing tips, mixing options, and key safety warnings.

The FDA clears Hepcludex, the first chronic hepatitis D therapy, offering new hope with strong viral suppression data and key safety monitoring needs.

New FDA guidance sharpens postmarket pregnancy drug safety data, improving labels and empowering pharmacists to report adverse events.

With Commissioner Makary resigning just days prior, this marks the second and third major change in the federal agency’s leadership this month.

The approval also includes an interchangeability designation, meaning both products can be substituted at the pharmacy level.

FDA leadership shifts as Marty Makary resigns amid drug, vaccine and mifepristone disputes; Kyle Diamantas steps in as acting commissioner.

FDA clears Langlara interchangeable insulin glargine, enabling pharmacy substitution for Lantus and widening affordable basal insulin access.

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.

This decision marks a historic milestone as sparsentan becomes the first and only medication specifically approved for this rare and devastating condition.

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.