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China’s NMPA approves Sintbilo for primary hypercholesterolemia and dyslipidemia – Innovent Biologics

Written by | 28 Aug 2023

Innovent Biologics announces that China’s National Medical Products Administration (NMPA) has approved Sintbilo (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including… read more.

Lynparza + abiraterone approved in Japan for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer – AstraZeneca + Merck Inc

Written by | 27 Aug 2023

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer… read more.

FDA approves first therapeutic indication for Daxxify for injection for the treatment of cervical dystonia – Revance Therapeutics

Written by | 26 Aug 2023

Revance Therapeutics, Inc. announced that the FDA has approved the first therapeutic indication for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults. Daxxify, powered… read more.

Forxiga approved in China to reduce the risk of cardiovascular death and hospitalisation in adult patients with symptomatic chronic heart failure – AstraZeneca

Written by | 25 Aug 2023

Forxiga (dapagliflozin) from AstraZeneca. has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with… read more.

FDA approval for Ingrezza Capsules for the treatment of chorea associated with Huntington’s disease – Neurocrine Biosciences Inc

Written by | 24 Aug 2023

Neurocrine Biosciences, Inc. announced the FDA has approved Ingrezza (valbenazine) capsules for the treatment of adults with chorea associated with Huntington’s disease (HD). Ingrezza is the only selective… read more.

EU approves Aquipta for prophylaxis of migraine – AbbVie

Written by | 23 Aug 2023

AbbVie announced that the European Commission has approved Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. The approval… read more.

First implant of Amvia Sky in Europe, the world’s first pacemaker approved for left bundle branch area pacing – Biotronik

Written by | 22 Aug 2023

The first implant in Europe of Biotroniks latest pacemaker and CRT-P generation was conducted in early August by Prof. Dr. Jan De Pooter at the University Hospital Ghent… read more.

FDA approval of Hepzato Kit for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma – Delcath Systems

Written by | 21 Aug 2023

Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that the FDA approved Hepzato Kit (melphalan/Hepatic Delivery… read more.

Arcutis and Huadong announce strategic collaboration and licensing agreement for topical roflumilast in Greater China and Southeast Asia

Written by | 20 Aug 2023

Arcutis Biotherapeutics, Inc. and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), announced that the companies have entered into a strategic… read more.

Elrexfio receives FDA accelerated approval for relapsed or refractory multiple myeloma – Pfizer

Written by | 19 Aug 2023

Pfizer Inc. announced the FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received… read more.

FDA approval for the POLARx cryoablation system for the treatment of patients with paroxysmal atrial fibrillation – Boston Scientific

Written by | 18 Aug 2023

Boston Scientific Corporation announced it has received FDA approval for the POLARx Cryoablation System.The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation… read more.

FDA approves Akeega, the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer – Janssen

Written by | 17 Aug 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Akeega (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor… read more.

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