Regulatory
The latest clinical hold was placed after a patient experienced serious adverse events that included neurotoxicity and cytomegalovirus infection, as well as severe respiratory distress.
In addition to the states agreeing to pause lawsuits, the FDA accepted Insys’ NDA for an opioid overdose medication.
Fusion Antibodies plc announces its final results for the year ended 31 March 2019.
Patented technology applied in SynGEM, a needle-free nasal spray vaccine against respiratory syncytial virus * Re-Issuance of U.S. Patent No. RE 47,471 further bolsters Mucosis’ intellectual property portfolio
BioArctic AB to publish the company’s Interim Report for the period January – June 2019 on Thursday, July 11, 2019 at 08:00 a.m. CET.
Only days after it was announced that Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration (FDA), was joining Pfizer’s board of directors, presidential hopeful Senator Elizabeth Warren (D-Mass) called for him to resign from the position.
Companies from across the globe provide information on agreements and pipeline updates.
Immigration has been a central concern of President Donald Trump. Since taking office, his administration has put forth a number of policies to restrict the number of immigrants allowed each year, as well as from what nations those immigrants can come.
Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.
FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report.
PRESS RELEASES