FDA News and Regulatory Updates

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.

FDA approves orforglipron, a once-daily oral GLP‑1 for weight management, taken with food or coffee—simplifying obesity treatment.

Your daily dose of the clinical news you may have missed.

The approval of Foundayo (orforglipron) marks a formulation milestone in obesity pharmacotherapy, offering a once-daily pill free of the fasting requirements that may complicate adherence.

From new oral options for for psoriatic disease to once-weekly insulin, 5 FDA decisions with implications for primary care practice.

Your daily dose of the clinical news you may have missed.

From oral GLP-1s for obesity and T2D to a potential first new smoking cessation drug in 20 years, here are 5 FDA pipeline updates to put on your radar.

The FDA has approved Awiqli® (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes, reducing injections from 7 to 1 per week.

New FDA-approved semaglutide 7.2 mg shows ~21% weight loss, offering primary care clinicians a higher-efficacy obesity treatment option.

Linda Stein Gold, MD, discusses recognizing when psoriasis patients need systemic therapy, and how icotrokinra's once-daily oral dosing can change the conversation.

FDA clears MiniMed Flex insulin pump with smartphone control and adaptive algorithm for type 1 and insulin-requiring type 2 diabetes.

FDA clears once-daily icotrokinra pill for moderate-to-severe plaque psoriasis, with strong PASI responses and placebo-like safety.

Deucravacitinib (Sotyktu) is the first TYK2 inhibitor approved for the treatment of PsA.

New FDA approvals span swallowable obesity balloon, dupilumab for fungal sinusitis, oral desmopressin, updated menopause labels, and sildenafil film.