Biopharma

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FDA Issues Draft Guidance on Including Tissue Biopsies ...

The FDA issued draft guidance that, when finalized, will provide recommendations...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The FDA issued draft guidance to provide recommendations on the use of artificia...

FDA Issues Comprehensive Draft Guidance for Developers ...

Today, the U.S. Food and Drug Administration issued draft guidance that includes...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The FDA published new draft guidance aimed at helping improve the accuracy and p...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...

FDA Approves Novel Non-Opioid Treatment for Moderate to...

The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-cl...

FDA Roundup: January 17, 2025

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

Dual-Targeted Therapies Plus Chemo Improve Objective Re...

TUESDAY, Feb. 4, 2025 -- For patients with BRAF V600E-mutant metastatic colorect...

Recording of Nystagmus During Vertigo in Meniere Diseas...

TUESDAY, Feb. 4, 2025 -- Nystagmus during vertigo attacks in patients with Menie...

Transcutaneous Electrical Stimulation Aids Gastroesopha...

TUESDAY, Feb. 4, 2025 -- A transcutaneous electrical stimulation system (TESS) i...

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