Regulation

Roche gets FDA approval for Hemlibra for haemophilia A without factor VIII inhibitors

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 submits NDA in US for Feraccru to treat iron deficiency

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, Sanofi secure FDA nod for skin cancer drug Libtayo

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.

US DEA reschedules GW Pharmaceuticals’ Epidiolex to Schedule V

GW Pharmaceuticals said that EPIDIOLEX (cannabidiol) oral solution has been transferred to Schedule V restriction classification, by the US Drug Enforcement Administration (DEA).

FDA accepts Samsung Bioepis’ BLA for Humira biosimilar

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’s acute radiation syndrome therapy gets FDA orphan drug status

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).

CHMP issues positive opinion supporting Trelegy Ellipta’s use in broader group of COPD patients

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 plans to file for new Lucentis indication in ROP

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, Fujifilm Kyowa get EC nod for Humira biosimilar Hulio

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.