Pharmaceutical Research and Manufacturers of America asks FDA to take some specific follow-up steps to its virtual meeting on advancing the developmen...
FDA increases its educational outreach to decrease hesitancy with biosimilar usage.
FDA grants Mesoblast an orphan-drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart condition hypoplastic le...
A Regulatory Affairs Professionals Society online post says FDA is several weeks late in delivering a congressionally mandated guidance on clinical tr...
Harvard Medical School professor Peter Cohen blasts FDA for a lack of sufficient action to remove harmful dietary supplements from the marketplace.
FDA denies a Zydus petition asking the action to take actions about the indomethacin suppository reference standard.
FDA releases the form FDA-483 with nine observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturing facility.
Citius Pharmaceuticals resubmits a BLA for Lymphir (denileukin diftitox) for treating patients with relapsed or refractory cutaneous T-cell lymphoma.
