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May 02, 2015
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
April 27, 2015
Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.
April 03, 2015
GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.
March 30, 2015
Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.
March 26, 2015
FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.
March 25, 2015
Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.
March 24, 2015
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
March 23, 2015
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
March 13, 2015
BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.