Regulation

Pfizer receives positive CHMP opinion for TALZENNA for patients with inherited BRCA-mutated locally advanced or metastatic breast cancer

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU).

GSK gets FDA nod for Benlysta to treat pediatric patients with lupus

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE).

Knopp Biosciences gets FDA orphan drug designation for dexpramipexole tp treat hypereosinophilic syndrome

Knopp Biosciences announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES).

FDA approves Merck’s Keytruda plus Inlyta to treat advanced renal cell carcinoma

Merck has secured approval from the US Food and Drug Administration (FDA) for Keytruda in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Viela Bio receives US FDA breakthrough therapy designation for Inebilizumab to treat Neuromyelitis Optica Spectrum Disorder

Viela Bio announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD).

AqVida, Phyton receive approval from EDQM for AqVida’s paclitaxel injectable FDF

Phyton Biotech, a German/North American Plant Cell Fermentation (PCF) technology company, and AqVida, a German oncology Finished Dosage Formulation (FDF) manufacturer, are pleased to announce today that they have received European approval from the EDQM (European Directorate of Quality Medicines) for AqVida’s paclitaxel injectable FDF.

FDA approves DUAKLIR PRESSAIR to treat chronic obstructive pulmonary disease

Circassia Pharmaceuticals announced that the US Food and Drug Administration has approved DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

FDA grants orphan drug designation to NeoImmuneTech’s Hyleukin-7 for idiopathic CD4+ lymphocytopenia treatment

NeoImmuneTech (NIT), a T cell-focused therapeutics company, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Hyleukin-7T, a T cell amplifier, in development for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL).

FDA accepts Novartis’s BLA for brolucizumab for treatment of wet AMD

Novartis said that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for brolucizumab (RTH258) as a potential treatment for wet age-related macular degeneration (AMD).