News
FDA approves six denosumab biosimilars
<p>In August and September 2025, the US Food and Drug Administration (FDA) approved six denosumab biosimilars, expanding treatment options for patients with bone ...
Bio-Thera and Stada expand biosimilars alliance to include tocilizumab
<p>Bio-Thera and STADA have expanded their strategic biosimilars alliance to include a tocilizumab product. The agreement grants STADA exclusive commercialization rights across Europe, ...
New guidance for biologicals in Pakistan and Hong Kong’s independent drug regulatory authority
<p>In July 2025, the Drug Regulatory Authority of Pakistan (DRAP) published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally ...
EMA recommends approval for four biosimilars targeting three therapies
<p>On 24 July 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing ...
Advancing biologicals regulation in Argentina: from registration to global harmonization
<p>Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) enforces a robust biologicals ...
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