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June 08, 2021
An ANDA from Sandoz for albuterol sulfate inhalation aerosol was approved by FDA.
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.
FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.
FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of plasminogen deficiency type 1.
FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.
June 07, 2021
FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.
The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.