Drug Filing

Lynparza maintenance therapy secures FDA priority review for ovarian cancer

AstraZeneca and Merck have secured priority review from the US Food and Drug Administration (FDA) for Lynparza as a maintenance therapy for patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer.

Seattle Genetics files supplemental application in US for expanded use of Adcetris

Seattle Genetics has filed a supplemental Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of CD30-expressing peripheral T-cell lymphoma (PTCL), based on data from the phase 3 ECHELON-2 trial.

Eiger’s lonafarnib secures RPD designation from FDA to treat Progeria

Eiger BioPharmaceuticals has secured the Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for lonafarnib to treat both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies.

Kala Pharmaceuticals submits NDA to FDA for KPI-121 0.25% to treat dry eye disease

Kala Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for KPI-121 0.25%, a topical product candidate being developed for the temporary relief of signs and symptoms of dry eye disease.

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).