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Sacituzumab Govitecan Approaches EU Approval for Pretreated HR+ Metastatic Breast Cancer

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptorโ€“positive, HER2-negative breast cancer.
Comunidad Autonoma De Cataluna United States Javier Cortes International Breast Cancer Center European Medicines Agency Medicinal Products

European Medicines Agency recommends Adtralza 2 ml pen for patients with atopic dermatitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion of Adtralza for injection in a new single-dose 2 ml pre-filled pen, according to a press release. Adtralza (tralokinumab, LEO Pharma), a high-affinity fully human monoclonal antibody, has previously been approved for a single dose injection of 150 mg from a 1 ml pre-filled syringe
Kreesten Meldgaard Madsen European Commission European Medicines Agency Medicines Agency Medicinal Products Human Use
Source: healio.com

BioNTech : Pfizer and BioNTech Initiate Application to European Medicines Agency for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine

Pfizer and BioNTech Initiate Application to European Medicines Agency for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine •The application reflects guidance from EMA and other major health authorities to pr...
United Kingdom United States Fosun Pharma World Health Organization Committee For Medicinal Products Human Use European Commission

EMA validates marketing authorization for pediatric alopecia areata treatment

The European Medicines Agency has validated the marketing authorization application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents, Legacy Healthcare announced in a press release. The application is now under the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) review.
Saad Harti Kristen Dowd Committee For Medicinal Products Human Use European Medicines Agency Legacy Healthcare Medicinal Products
Source: healio.com

Legacy Healthcare Announces EMA Validation of Marketing Authorisation Application (MAA) for Coacillium for the treatment of Moderate and Severe Alopecia Areata in Children and Adolescents

/PRNewswire/ -- Legacy Healthcare (or the "Company"), today announced that its Marketing Authorisation Application (MAA) to the European Medicines Agencys...
Saad Harti Nadine Vincent European Medicines Agency Committee For Medicinal Products Human Use Head Of Regulatory Affairs Legacy Healthcare National Alopecia Areata Foundation

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BBCNEWS HARDtalk June 4, 2024 22:32:00

Well, it failed to achieve what i had hoped it would achieve and what i believe ethically it needs to achieve, thats true. it didnt totally fail because there is now an animal rights movement which is a powerfulforce in many of the countries in the world and many people kindly credit my book as having triggered or inspired that movement. and that movement has had some achievements in some countries, i wouldnt deny that, but if we look at it globally, there are more animals in factory farms than ...
It Didn T Animal Rights Movement Human Use Human Beings Isn T

FDA Approves Genentech's Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

- Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, and a median duration of response of 1.5 years (18.4 months) - - Given over
United States South San Francisco Bruno Eschli Loren Kalm Lindsey Mathias Levi Garraway

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