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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.

FDA approves Talvey a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma – Janssen Pharma

Written by | 15 Aug 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has granted accelerated approval of Talvey (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult… read more.

US CDC recommends Beyfortus for prevention of respiratory syncytial virus – Sanofi /AstraZeneca

Written by | 14 Aug 2023

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZeneca’s… read more.

FDA approves Izervay for geographic atrophy – Astellas/Iveric

Written by | 12 Aug 2023

Astellas Pharma Inc announced the FDA approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4,… read more.

FDA approves expanded indication for Ervebo in Zaire ebolavirus – Merck Inc

Written by | 11 Aug 2023

Merck Inc announced that the FDA has approved an expanded indication for Ervebo, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals… read more.

Abbott initiates US market withdrawal of Trifecta family of heart valves

Written by | 10 Aug 2023

Abbott is initiating a US market withdrawal for the Trifecta family of valves and will be removing the limited remaining inventory from the field. On February 27, 2023,… read more.

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