Drug Filing

UK’s NICE seeks additional data on blood cancer drug Blincyto

The National Institute for Health and Care Excellence (NICE) in the UK is seeking additional data on Amgen’s Blincyto (blinatumomab) to treat adults with acute lymphoblastic leukaemia (ALL).

US FDA grants priority review for Fedratinib new drug application in myelofibrosis

Celgene announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for fedratinib and granted a Priority Review.

FDA grants priority review and accepts sBLA of SOLIRIS as treatment for NMOSD

Alexion Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the use of SOLIRIS (eculizumab), the company’s first C5 complement inhibitor, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies.

Roche secures FDA priority review for entrectinib and polatuzumab vedotin

Roche has secured priority review from the US Food and Drug Administration (FDA) for two of its investigational cancer drugs, the selective tyrosine kinase inhibitor entrectinib (RXDX-101) and the anti-CD79b antibody drug conjugate (ADC) polatuzumab vedotin.

FDA extends review period for Incyte’s GVHD treatment Jakafi

The US Food and Drug Administration (FDA) has extended the review period for Incyte’s supplemental new drug application (sNDA) for acute graft-versus-host disease (GVHD) treatment Jakafi (ruxolitinib).

AstraZeneca’s RSV drug MEDI8897 gets FDA’s breakthrough therapy designation

AstraZeneca’s MEDI8897 has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV).

Roche seeks FDA approval for Kadcyla in HER2-positive early breast cancer

Roche has submitted a supplemental biologics license application (sBLA) in the US seeking approval for Kadcyla (trastuzumab emtansine) for the adjuvant treatment of a type of early breast cancer.

FDA accepts X-Rx’s IND application for X-165 to treat IPF

The US Food and Drug Administration (FDA) has accepted X-Rx's investigational new drug application (IND) for X-165 being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Rocket Pharmaceuticals announces clearance of IND for RP-A501 gene therapy for Danon disease

Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy company, today announces the clearance of the Company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for RP-A501.