Lannett says FDA has granted it a 6/9 Biosimilar Biological Product Development Type 2 meeting to plan next steps for the clinical development of its ...
FDA extends by three months its review of a Roche NDA for risdiplam and its use in treating spinal muscular atrophy.
Multiple former FDA officials question the wisdom of the agency granting an emergency use authorization for two malaria medicines to be used against t...
The Justice Department says Pentax Medical is paying $43 million to resolve criminal charges resulting from its decision not to use revised FDA cleani...
FDA approves Ciplas generic form of Proventil HFA metered-dose inhaler.
CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel discusses the growing importance of serology tests for Covid-19 d...
FDA says it recommends additional safety protections be used with fecal microbiota for transplantation.
FDA accepts for review a Liquidia Technologies 505(b)(2) NDA for LIQ861 (treprostinil) for treating pulmonary arterial hypertension.