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FDA approves Jardiance for the treatment of type 2 diabetes in children 10 years and older – Boehringer Ingelheim + Eli Lilly

Written by | 27 Jun 2023

The FDA has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with… read more.

Health Canada approves Xcopri to treat partial offset seizures – Paladin Labs

Written by | 26 Jun 2023

SK Biopharmaceuticals said that Health Canada granted a Notice of Compliance for Xcopri (ingredient: cenobamate), its epilepsy drug, approving its application for marketing authorization in Canada. Paladin Labs,… read more.

Publication of phase III FRESCO-2 results evaluating fruquintinib in patients with previously treated colorectal cancer in The Lancet – Takeda and HutchMed

Written by | 25 Jun 2023

Takeda and HUTCHMED (China) Limited announced that results of the Phase III FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in… read more.

FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome – Ipsen

Written by | 24 Jun 2023

Ipsen announced that the FDA has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). Bylvay is… read more.

Additional data from phase IV Tepezza clinical trial presented at the Endocrine Society annual meeting reinforces efficacy in people with thyroid eye disease (TED) regardless of disease activity or duration – Horizon Therapeutics / Amgen

Written by | 23 Jun 2023

Horizon Therapeutics plc announced the presentation of new data from the randomized, double-masked, placebo-controlled Phase IV clinical trial (NCT04583735) evaluating Tepezza in patients with long disease duration and… read more.

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.

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