OR WAIT null SECS
January 02, 2018
Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
December 20, 2017
New tax legislation may result in savings for biopharma companies.
FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
December 19, 2017
EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.
The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.
December 18, 2017
The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.
The agency published guidance on the research and development of individualized therapies.