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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.

Kisqali significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent .across subgroups – Novartis

Written by | 10 Jun 2023

Novartis presents positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting . Data showed that… read more.

Presentation of new Lumakras CODEBREAK 200 CNS data at ASCO 2023 meeting – Amgen

Written by | 9 Jun 2023

Amgen announced the presentation of new data from the CodeBreaK clinical trial program, the most comprehensive global development program in patients with KRAS G12C-mutated cancers, at the American… read more.

EU approves Briumvi in adults with relapsing multiple sclerosis – TG Therapeutics

Written by | 8 Jun 2023

TG Therapeutics announced that the European Commission (EC) has granted approval of Briumvi (ublituximab xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS)… read more.

Keytruda + chemotherapy before surgery and continued as a single agent after surgery reduced the risk of event-free survival events by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB NSCLC – Merck Inc

Written by | 7 Jun 2023

Merck known as MSD outside of the United States and Canada, announced positive results from the pivotal Phase III KEYNOTE-671 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, as a… read more.

Presentation of Ingezza capsules data on tardive dyskinesia improvement regardless of baseline antipsychotic use at 2023 Psych Congress Elevate – Neurocrine Biosciences

Written by | 6 Jun 2023

Neurocrine Biosciences, Inc. presented findings from a meta-analysis of three long-term studies evaluating Ingrezza (valbenazine) capsules that demonstrated substantial and sustained improvements in tardive dyskinesia (TD) in adults… read more.

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