Regulatory Oversight and Compliance

Immodulon Gains Allowability of Claims for Key European Patent Application

June 11, 2021

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process

June 10, 2021

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

FDA Approves ANDA for Albuterol Sulfate

June 08, 2021

An ANDA from Sandoz for albuterol sulfate inhalation aerosol was approved by FDA.

Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents

June 08, 2021

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

FDA Publishes Guidance Documents to Enhance Supply Chain Security

June 08, 2021

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for NASH Treatment

June 08, 2021

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 Approves Treatment for Plasminogen Deficiency Type 1

June 08, 2021

FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of plasminogen deficiency type 1.

Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb

June 08, 2021

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

June 07, 2021

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

Biden Budget “Wish List” Maps FDA and Health Care Priorities

June 07, 2021

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.