Drug Filing

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.

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”).

Silence’s SLN124 gets orphan designation in Europe for β-Thalassemia

Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia.

Pfizer’s tafamidis secures FDA priority review for ATTR-CM

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).

Ocular seeks FDA nod for expanded indication of Dextenza eye treatment

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.

Momenta revises regulatory strategy for proposed Humira biosimilar

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.