Articles related to DEVICE/DRUG APPROVALS

Lerochol (lerodalcibep-liga), a once-monthly self-administered PCSK9 inhibitor, is now commercially available as adjunctive LDL-C-lowering therapy for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

The FDA approved dextromethorphan-bupropion (Auvelity) for agitation associated with dementia due to Alzheimer’s disease, based on phase 3 trial data and a long-term randomized withdrawal study.

The FDA approved a supplemental NDA adding randomized withdrawal trial data to the lumateperone label, supporting its role in long-term maintenance and relapse prevention in adults with schizophrenia.

The FDA approved vepdegestrant for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer after endocrine therapy progression, marking the first regulatory approval of a PROTAC drug.

Sdamlo’s FDA approval offers a new oral solution option for delivering amlodipine, addressing administration challenges in patients who cannot tolerate tablets.

FDA approval of 20‑week dosing for Eylea HD offers eligible wAMD and DME patients the potential for fewer injections while maintaining long‑term visual outcomes.