News

EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID?19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be...

Biogen entered into an agreement to jointly develop and commercialise Sage Therapeutics' zuranolone for major depressive disorder (MDD) and postpartum depression (PDD), as well as SAGE-324 for essential tremor, the companies announced Friday. Under the deal, Biogen will pay...

AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving standard of care. HF is a life-threatening chronic disease that prevents the heart from pumping sufficient levels of blood...

Lonza AG has announced a significant investment to expand its particle engineering and drug product capabilities to meet increased market demand at its Bend, Oregon site. New suites for the development and clinical manufacture of drug product intermediates and...

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases...

Moderna, Inc. , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273,...

The Wasdell Group, a leading outsourcing partner to companies in the pharmaceutical and biotech sector, has  announced that its Dundalk, Ireland facility has been certified to comply with the ISO 13485 standard for medical device manufacturing. The ISO 13485 is...