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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
International pharmacovigilance can be challenging, particularly for small biotechs.
Understanding a CAPA request is step one in developing a robust plan to address CGMP deficiencies.
Decontamination, automation, and containment are important considerations.
June 10, 2021
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
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.
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
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.
June 03, 2021
In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.