The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.
Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.
The U.S. Food and Drug Administration rejected Allergan’s New Drug Application for ulipristal acetate.
A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.
The European Medicines Agency said a second Chinese contract manufacturer, Zhejiang Tianyu, produced a common blood pressure and heart drug with an impurity that could cause cancer.
JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab Biosimilar to Treat Lung Cancer
JHL Biotech received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed bevacizumab biosimilar JHL1149 to treat patients with non-small cell lung cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a Positive Opinion over Alnylam Pharmaceuticals’ patisiran for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy.
GlaxoSmithKline’s Nucala won a key recommendation from a European Medicines Agency panel for use in the treatment of children with severe asthma.
AstraZeneca’s cancer drug Imfinzi won a key recommendation from a European Medicines Agency (panel less than six months after the first global approvals in Western markets.