Here are the open status categories for FDA postmarketing requirements and commitments listed.

SGLT2 inhibitors not only can effectively lower blood sugar, but also bring significant cardiorenal protective effects.

PAES, as mandated by EU Commission Delegated Regulation No 357/2014, refers to an efficacy study required by a Competent Authority under any of the specified conditions outlined in the regulation.

Mission Therapeutics reveals that the FDA has given the green light to start a Phase II study for their prime candidate, MTX652, targeting Acute Kidney Injury.

Rolling Review is a process used by the US Food and Drug Administration (FDA) to expedite the review of new drug applications.

On Dec 2, 2023, results from a Penpulimab-based neoadjuvant/adjuvant therapy trial for resectable advanced non-small cell lung cancer were presented at ESMO_ASIA 2023.

The term 'postmarketing requirement' (PMR) refers to mandatory post-approval studies or trials, including those mandated by the FDAAA, 21 CFR part 314 subpart H, 21 CFR part 601 subpart E, the Pediatric Research Equity Act, and the Animal Efficacy Rule.

Halia Therapeutics initiated treatment with HT-6184, a novel NLRP3 inhibitor, in an initial participant for its early-stage Phase 2a study aimed at addressing lower-risk types of myelodysplastic conditions.

Serious risk means a risk of a serious adverse drug experience.

Thrombin inhibitors are drugs that specifically target and inhibit thrombin, a key enzyme in blood clotting.

Guillain-Barré syndrome (GBS) is a rare disorder in which a person’s own immune system damages the nerve cells, causing muscle weakness and sometimes paralysis.

Agomab Initiates First-Stage Research Trial on AGMB-447 with Healthy Participants and Individuals Diagnosed with Idiopathic Pulmonary Fibrosis.