Industry Dynamics

Industry News

12-28

2020

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Dec. 23, 2020-- Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic r……

12-15

2020

Novartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year

December 22, 2020 — Novartis announced today that the European Commission (EC) has approved Leqvio®* (inclisiran) for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. This approval is based on the……

11-25

2020

FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

November 20, 2020 -- Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing……

11-09

2020

Brilinta approved in the US to reduce the risk of stroke in patients with an acute ischaemic stroke or high-risk transient ischaemic attack

November 06, 2020 –AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institu……

10-30

2020

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

October 25, 2020 -- MSD, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-2 therapy, as monotherapy for the treatment of adult patients with re……

10-09

2020

Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and Adults

October 5, 2020 – Kyowa Kirin Co., Ltd. today announced that the European Commission (EC) has approved CRYSVITA® (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia (XLH).……

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