Drug Filing

FDA and EMA accept Novartis’ filings for MS drug Siponimod

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ new drug application (NDA) and marketing authorization application (MAA) for multiple sclerosis drug siponimod (BAF312).

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.

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).

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.

OBI Pharma’s OBI-3424 gets FDA orphan drug status to treat ALL

OBI Pharma’s small-molecule prodrug OBI-3424 has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute lymphoblastic leukemia (ALL).

Ironwood secures FDA fast track designation for heart drug praliciguat

Ironwood Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer

The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.