Articles related to DEVICE/DRUG APPROVALS

Adding niraparib to abiraterone prolonged radiographic progression-free survival in BRCA-mutant metastatic hormone-sensitive prostate cancer, with overall survival data still maturing.

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.