Posts

GSK launches £2bn buyback on strong HIV and cancer drug...

UK pharma group raises long-term annual sales forecast to more than £40bn by 2031

Rapid trials prompt deals rush for Chinese ‘super me-to...

Western drugmakers look to Chinese trials for early data on treatments’ potentia...

Meeting highlights from the Committee for Veterinary Me...

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus...

Meeting highlights from the Pharmacovigilance Risk Asse...

Medicines containing semaglutide: PRAC investigating risk of rare eye conditionP...

Human medicines in 2024

In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46...

Revised rules on handling of competing interests published

EMA has published the revised version of its policies on the handling of competi...

New EU rules for health technology assessments become e...

EMA is ready to support the implementation of the new regulation on health techn...

Clinical Trials Regulation becomes fully applicable

From today, all clinical trials in the European Union (EU), including ongoing tr...

Meeting highlights from the Committee for Medicinal Pro...

Eight new medicines recommended for approvalEMA’s human medicines committee (CHM...

One Health: EU agencies unite to tackle azole fungicide...

For the first time, the five EU health and environment agencies – EFSA (European...

European Shortages Monitoring Platform fully operationa...

The European Shortages Monitoring Platform (ESMP) is now live with the full scop...

EMA celebrates 30 years of progress in science and medi...

EMA is celebrating 30 years of operations marking its evolving role at the centr...

Two new vaccines against bluetongue recommended for app...

EMA has recommended the approval of the vaccines Bluevac-3 and Syvazul BTV 3 to ...

FDA Approves First Acellular Tissue Engineered Vessel t...

FDA approved Symvess, the first acellular tissue engineered vessel for use in ad...

FDA Issues Draft Guidance on Including Tissue Biopsies ...

The FDA issued draft guidance that, when finalized, will provide recommendations...

FDA Proposes Framework to Advance Credibility of AI Mod...

The FDA issued draft guidance to provide recommendations on the use of artificia...

FDA Issues Comprehensive Draft Guidance for Developers ...

Today, the U.S. Food and Drug Administration issued draft guidance that includes...

FDA Proposes Updated Recommendations to Help Improve Pe...

The FDA published new draft guidance aimed at helping improve the accuracy and p...

FDA Roundup: January 3, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of new...

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Produ...

Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN ...

FDA Proposes Significant Step Toward Reducing Nicotine ...

FDA issued a proposed rule that, if finalized, would make cigarettes and certain...

FDA Roundup: January 14, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of new...

FDA Proposes Requiring At-a-Glance Nutrition Informatio...

FDA announces a proposed rule requiring food manufacturers to display a front-of...

FDA Roundup: January 10, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of new...

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