Diana Ernst

US FDA approves Inqovi® in combination with venetoclax, the first all-oral combination treatment for patients with acute myeloid leukemia who are ineligible for intensive induction chemotherapy.

The Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for sevabertinib for the first-line

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Enhertu® (fam-trastuzumab deruxtecan-nxki) approved in the US for two new indications for patients with HER2-positive early breast cancer. News release. AstraZeneca. May 15, 2026.

BridgeBio announces FDA acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9. News release. BridgeBio. May 27, 2026.

History of retentive posturing or excessive volitional stool retention; History of painful or hard bowel movements;

Topline results were announced from a phase 3 trial evaluating pozdeutinurad, an investigational oral URAT1 inhibitor designed to lower serum uric acid (sUA) in patients with gout.

MannKind announces FDA approval of Afrezza ® , the first and only inhaled mealtime insulin for use in children and adolescents aged 6 and older living with diabetes.

Shionogi announces FDA approval of Xocova ® (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure.

FDA grants Fast Track designation to Merakris' MTX-001, opening potential accelerated path to market for venous leg ulcer therapy. News release. Merakris. June 2, 2026.