Roche has secured approval from the US Food and Drug Administration (FDA) for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients of all ages having haemophilia A without factor VIII inhibitors.
Shield Therapeutics has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for its lead product Feraccru to treat iron deficiency.
Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for their Libtayo (cemiplimab-rwlc) to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
GW Pharmaceuticals said that EPIDIOLEX (cannabidiol) oral solution has been transferred to Schedule V restriction classification, by the US Drug Enforcement Administration (DEA).
The US Food and Drug Administration (FDA) has accepted for review Samsung Bioepis’ Biologics License Application (BLA) for SB5, a biosimilar for HUMIRA (adalimumab).
Myelo Therapeutics’ orally applied new chemical entity Myelo001 has secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of acute radiation syndrome (ARS).
GlaxoSmithKline (GSK) and Innoviva secured positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the expanded use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol FF/UMEC/VI) in moderate to severe chronic obstructive pulmonary disease (COPD).
Novartis has unveiled plans to file ex-US for a new indication for Lucentis (ranibizumab) in retinopathy of prematurity (ROP), a rare disease in premature infants.
Mylan and Fujifilm Kyowa Kirin Biologics have secured marketing authorization from the European Commission (EC) for their Hulio, a biosimilar to AbbVie's Humira (adalimumab), for all indications.
The Australian Competition and Consumer Commission (ACCC) has decided not to oppose the merger of generic pharmaceutical companies Arrow and Apotex after finding that the transaction would not reduce competition in any market.
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