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Sage Therapeutics announces a strategic reorganisation

Written by | 2 Nov 2024

Sage Therapeutics, Inc. announced a strategic reorganization of its business operations to support the ongoing launch of Zurzuvae in postpartum depression and focus pipeline development efforts ahead of… read more.

FDA approves Botox Cosmetic (onabotulinumtoxinA) for temporary improvement in platysma bands in adults – Allergan/AbbVie

Written by | 1 Nov 2024

Allergan Aesthetics, an AbbVie company announced the FDA approval of Botox Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and… read more.

Rigel Pharmaceuticals issues Dear Health Care Provider letter relating to Gavreto (pralsetinib)

Written by | 31 Oct 2024

Rigel Pharmaceuticals, Inc.  announced it is issuing a Dear Health Care Provider (DHCP) letter related to a new safety signal for Gavreto (pralsetinib) after consultation with the FDA…. read more.

Dupixent late-breaking positive phase III data in chronic spontaneous urticaria to be presented at ACAAI – Sanofi

Written by | 30 Oct 2024

Positive data from the phase III LIBERTY-CUPID Study C evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background… read more.

TEAM-HF trial to measure pulmonary pressures using CardioMEMS HF System – Abbott

Written by | 29 Oct 2024

Abbott announced a new, first-of-its-kind clinical trial designed to improve outcomes in patients with worsening heart failure who could benefit from advanced therapy options. The TEAM-HF trial, which… read more.

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years – Bayer

Written by | 28 Oct 2024

Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PHOTON in patients with diabetic macular edema (DME) at three years,… read more.

CHMP positive for Kevzara (sarilumab) to treat polymyalgia rheumatica – Sanofi

Written by | 27 Oct 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Kevzara…. read more.

MHRA (UK) approves donanemab to treat mild cognitive impairment and mild dementia in the UK – Eli Lilly

Written by | 26 Oct 2024

Eli Lilly and Company announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks… read more.

Gilead Sciences to withdraw Trodelvy (sacituzumab govitecan-hziy) for bladder cancer in the US

Written by | 25 Oct 2024

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy (sacituzumab goviteca-hziy) as a bladder cancer treatment in the U.S. Gilead Sciences announced… read more.

CHMP positive for Flucelvax vaccine to prevent influenza

Written by | 24 Oct 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Flucelvax, intended for the prevention of influenza… read more.

FDA approves the Versius Surgical System

Written by | 23 Oct 2024

CMR Surgical announced that the FDA has granted marketing authorization for the Versius Surgical System (Versius), paving the way for a next-generation versatile, adaptable, and digitally driven surgical… read more.

FDA approves Vyalev (foscarbidopa + foslevodopa) subcutaneous 24-hour infusion of levodopa-based therapy for advanced Parkinson’s disease – AbbVie

Written by | 22 Oct 2024

AbbVie announced that the FDA has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations… read more.

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