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.
Puma Biotechnology said a European Medicines Agency committee was likely to give a positive opinion on its breast cancer drug neratinib five months after the regulator recommended against it.
The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said.
J&J’s Janssen Pharmaceutical Companies submitted a Marketing Authorization Application to the EMA for apalutamide for non-metastatic castration-resistant prostate cancer.
Novo Nordisk came closer to winning European approval for the company’s diabetes drug Ozempic, the Danish drugmaker’s largest growth prospect, when a European Medicines Agency experts’ panel issued a positive recommendation.
Pfizer’s big-selling erectile dysfunction drug Viagra was given a green light for sale without a prescription in Britain, the first country to grant it over-the-counter status.
Novartis submitted its cell therapy Kymriah for European approval in two forms of blood cancer, seeking to expand the use of the new treatment.
Access to new medicines and safety checks on existing treatments will be jeopardized if politicians pick a new home for Europe’s London-based drugs regulator that is unacceptable to staff, its executive director told Reuters.
Roche received European approval for its Actemra medication in giant cell arteritis (GCA) and Gazyvaro for people with previously untreated advanced follicular lymphoma.
European regulators granted market approval for Merck KGaA and Pfizer’s immuno-oncology drug Bavencio to treat a rare and aggressive type of skin cancer called Merkel cell carcinoma.
A biosimilar version of AbbVie Inc.’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc. and Samsung Biologics, was approved by EU regulators.