trending Market Intelligence /marketintelligence/en/news-insights/trending/2J-VCLvS42x_q8VgRHD4Eg2 content esgSubNav
In This List

Approvals for Kyowa Kirin, Eli Lilly; designations for AstraZeneca, Akari

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Approvals for Kyowa Kirin, Eli Lilly; designations for AstraZeneca, Akari

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 30.

Approvals

* Kyowa Kirin Co. Ltd.'s Nourianz as an add-on treatment for adults with Parkinson's disease experiencing so-called off episodes — times when a patient's medications are not working well and symptoms, such as tremor and difficulty walking, increase.

* Eli Lilly and Co.'s Taltz injection for adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis.

* Mylan NV's generic version of Eli Lilly's lung cancer drug Alimta. The FDA granted tentative approval to Mylan.

* Alcon Inc.'s AcrySof IQ PanOptix trifocal intraocular lens for patients undergoing cataract surgery.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: Associated Press

Fast track

* AstraZeneca PLC's Farxiga in delaying the progression of renal failure, as well as prevent cardiovascular and renal death in chronic kidney disease patients, with or without type 2 diabetes.

Other designations: orphan drug

* AstraZeneca's Fasenra for eosinophilic esophagitis.

* Akari Therapeutics PLC's nomacopan for patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy.