FDA News and Regulatory Updates

The US FDA approved enlicitide (Lipfendra; Merck), the first oral PCSK9 inhibitor, to reduce LDL-C in adults with hypercholesterolemia, including HeFH.

Catch up on the 7 FDA drug approvals most relevant to primary care, including new options for hypertension, weight management, acne, and more.

FDA authorized a reduced-risk claim for 20 ZYN nicotine pouches for adults who switch completely from cigarettes.

Recent FDA actions include updates on COVID-19 prophylaxis, ADHD, PTSD neuromodulation, and pediatric psoriasis and psoriatic arthritis care.

FDA approved roflumilast (Zoryve) cream 0.3% for plaque psoriasis in children as young as age 2, expanding the once-daily steroid-free topical indication.

FDA approved risankizumab for children aged 6 years or older with moderate to severe plaque psoriasis or active psoriatic arthritis.

The CRL cites deficiencies at a third-party manufacturing facility, with no efficacy or clinical safety deficiencies identified.

The EEG-guided MeRT system is the first personalized, biomarker-guided neuromodulation technology to receive FDA clearance for PTSD.

Recent FDA updates include new actions in diabetes, hypertension, chronic HDV infection, bipolar depression, and CKD in type 1 diabetes.

The FDA today issued a Complete Response Letter for Cingulate’s CTx-1301 for ADHD, citing CMC-related requests and no current safety or efficacy concerns.

FDA approved ensitrelvir for COVID-19 postexposure prophylaxis in adults and adolescents aged 12 years and older after exposure.

FDA approval expands Afrezza as an inhaled mealtime insulin option for pediatric patients with diabetes aged 6 years and older.

Elunetirom received FDA Fast Track designation as an adjunctive therapy for bipolar depression, with phase 2 AMPLIFY-BD data expected in 2026.

FDA approved bulevirtide-gmod (Hepcludex; Gilead Sciences) for adults with chronic HDV infection without cirrhosis or with compensated cirrhosis, based on phase 3 data.

The approval indicates ocrelizumab for RRMS in patients older than 10 years who weigh 55 pounds or more and is supported by data from the OPERETTA II study.

FDA updates include oral GLP-1 therapy, HIV regimen, gene therapy for hearing loss, and diabetes technology advances.

The FDA approved dextromethorphan hydrobromide-bupropion hydrochloride for agitation associated with dementia due to Alzheimer disease.

Rachael Sood, NP-C, CDCES, outlines what the FDA clearance of Control-IQ+ for type 1 diabetes in pregnancy means for primary care practice.

The FDA approved updated labeling for lumateperone showing a 63% lower relapse risk in adults with schizophrenia in a phase 3 trial.

The FDA cleared Tandem's Control-IQ+ as the first AID system approved for pregnancy in type 1 diabetes, backed by the CIRCUIT trial.

Otarmeni is the first FDA-approved gene therapy for OTOF-related hearing loss, showing rapid hearing gains in the CHORD trial.

FDA approves doravirine/islatravir for adults with virologically suppressed HIV-1, offering a once-daily 2-drug regimen with noninferior efficacy.

Highlights include once-weekly insulin, obesity therapies, and new options for psoriasis and rare diseases.

Explore monthly GLP‑1 dose titration, unusual strength jumps, and color‑coded pills—plus tips for switching safely from injectable regimens.