The FDA has approved diazoxide choline extended-release tablets (Vykat XR – Soleno Therapeutics) for treatment of hyperphagia in patients ≥4 years old with Prader-Willi syndrome. Diazoxide choline is the first drug to be approved in the US for this indication. Diazoxide oral suspension (Proglycem) has been available for years for management of symptomatic hypoglycemia.

Relacorilant (Lifyorli – Corcept Therapeutics), an oral first-in-class glucocorticoid receptor antagonist, has been approved by the FDA for use in combination with nab-paclitaxel (Abraxane, and generics) for treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy, one of which included bevacizumab (Avastin, and others).

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

Lazertinib (Lazcluze – Janssen Biotech), an oral kinase inhibitor, has been approved by the FDA for use in combination with the EGFR-MET bispecific antibody amivantamab (Rybrevant) for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. This is the first approval for Lazcluze; amivantamab was previously approved for use alone and in combination with carboplatin and pemetrexed for treatment of NSCLC with EGFR exon 20 insertion...

Nerandomilast (Jascayd – Boehringer Ingelheim), an oral phosphodiesterase 4 (PDE4) inhibitor, has been approved by the FDA for treatment of idiopathic pulmonary fibrosis (IPF) in adults. It is the third drug to be approved in the US for this indication; the oral antifibrotic drugs pirfenidone (Esbriet, and generics) and nintedanib (Ofev) were approved in 2014.

Zidesamtinib (Jideytro – GSK), an oral kinase inhibitor, has been approved by the FDA for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults who received at least one prior ROS1 kinase inhibitor. It is the fifth oral kinase inhibitor to be approved in the US for treatment of ROS1-positive NSCLC; crizotinib (Xalkori), entrectinib (Rozlytrek), repotrectinib (Augtyro), and taletrectinib (Ibtrozi) were approved earlier.

The FDA has approved ensartinib (Ensacove – Xcovery), an oral kinase inhibitor, for treatment of anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have not previously received an ALK inhibitor (e.g, crizotinib [Xalkori], certinib [Zykadia], alectinib [Alecensa], brigatinib [Alunbrig], lorlatinib [Lorbrena]). All previously approved ALK inhibitors are also approved for first-line use.

Vusolimogene oderparepvec (Tudriqev – Replimune), a genetically-modified herpes simplex virus type 1 (HSV-1) oncolytic therapy, has been granted accelerated approval by the FDA for use in combination with the programmed death receptor-1 (PD-1)-blocking antibody nivolumab (Opdivo) for treatment of unresectable advanced cutaneous melanoma in adults who had disease progression on a PD-1-blocking antibody-based regimen. About 30-50% of patients develop primary resistance to anti-PD-1 therapy. The oncolytic viral therapy talimogene laherparepvec (Imlygic) was approved in 2015 for...

Auvelity (Axsome), an extended-release fixed-dose combination of dextromethorphan and bupropion that was approved by the FDA for treatment of major depressive disorder in 2022, has now been approved for treatment of agitation associated with dementia due to Alzheimer's disease (AD). It is the second product to be approved in the US for this indication; the oral second-generation antipsychotic drug brexpiprazole (Rexulti) was approved in 2023.

The FDA has approved Opill (Perrigo), a progestin-only oral contraceptive that contains norgestrel, for sale over the counter (OTC). Opill is the first oral contraceptive to be approved in the US for sale without a prescription. Approval of OTC Opill is intended to increase access to effective contraception and reduce the rate of unintended pregnancies.