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FDA approves Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Written by | 22 Jun 2023

Roche announced that the FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified… read more.

VBI Vaccines announces PreHevbri is now available in the United Kingdom for the prevention of hepatitis B in adults

Written by | 21 Jun 2023

VBI Vaccines Inc. announced that PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the United Kingdom for active immunization against infection caused by all known subtypes… read more.

First-of-its-kind head-to-head clinical trial reaffirms the efficacy of Emgality in episodic migraine prevention – Eli Lilly

Written by | 20 Jun 2023

Eli Lilly and Company announced results of the CHALLENGE-MIG clinical trial of Emgality (galcanezumab-gnlm) and Nurtec ODT (rimegepant orally disintegrating tablet), the first and only trial of its… read more.

Bayer starts phase II/III study with vericiguat in children with heart failure

Written by | 19 Jun 2023

Bayer and its development partner MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) announced that the first patient has been enrolled in the Phase II/III… read more.

Soliris approved in China for the treatment of adults with refractory generalised myasthenia gravis – AstraZeneca

Written by | 18 Jun 2023

Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris is the… read more.

FDA approves Injectafer to treat iron deficiency and heart failure – Daiichi Sankyo + American Regent Inc

Written by | 17 Jun 2023

Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, announced that the FDA approved Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency in… read more.

MHRA (UK) expands approval for Xeomin to treat focal spasticity of the lower limbs affecting the ankle joint – Merz Therapeutics

Written by | 16 Jun 2023

The MHRA (UK) has granted approval for a new indication for Merz Therapeutics’ Xeomin (incobotulinumtoxinA) to treat focal spasticity of the lower limbs affecting the ankle joint. The… read more.

European Commission approval for Pedmarqsi to reduce the risk of hearing loss in paediatric oncology patients – Fennec Pharma

Written by | 15 Jun 2023

Fennec Pharmaceuticals Inc.has announced Pedmarqsi– known as Pedmark in the U.S. – was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy… read more.

European Commission approval for Cosentyx as first and only IL-17A inhibitor for hidradenitis suppurativa – Novartis

Written by | 14 Jun 2023

Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to… read more.

Andexxa phase IV trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care – AstraZenca

Written by | 13 Jun 2023

ANNEXA-I, a post-marketing Phase IV trial to assess the efficacy and safety of Andexxa (andexanet alfa) from AstraZeneca in patients on oral FXa-inhibitor treatment including apixaban and rivaroxaban… read more.

Presentation of longer-term data for Tecvayli showing a duration of response of 22 months in patients with r/r multiple myeloma – Janssen

Written by | 12 Jun 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term data from the pivotal Phase 1/II MajesTEC-1 study showing the sustained efficacy and safety of Tecvayli (teclistamab-cqyv) in… read more.

EU approves Arexvy for respiratory syncytial virus – GSK

Written by | 11 Jun 2023

GSK announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by… read more.

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