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).
08 Feb 2019
06 Feb 2019
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).
05 Feb 2019
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.
25 Jan 2019
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).
23 Jan 2019
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.
21 Jan 2019
Lilly’s second immune-oncology candidate using Zymeworks’ Azymetric platform to start clinical trials
Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company (“Lilly”).
16 Jan 2019
Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia.
15 Jan 2019
Pfizer’s tafamidis meglumine form (20mg capsule) has secured priority review from the US Food and Drug Administration (FDA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).
11 Jan 2019
Ocular Therapeutix is seeking approval from the US Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert) to expand the current indication to include the treatment of ocular inflammation following ophthalmic surgery.
04 Dec 2018
Momenta Pharmaceuticals has revised its regulatory strategy in the US for its anti-FcRn antibody M923, which is being proposed by the company as a biosimilar to Humira.