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Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.
March 30, 2015
Drug makers back alternative to FDA labeling update rule.
Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.
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.
Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.
March 23, 2015
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
March 18, 2015
A new machine is designed for inspection of prefilled syringes.
Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.
WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.