Drug Filing

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.

FDA fast tracks Novartis’ Zolgensma SMA gene replacement therapy

Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec-xxxx), which was formerly known as AVXS-101, has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA) Type 1.

AstraZeneca’s Fasenra secures FDA orphan drug designation for EGPA

AstraZeneca’s respiratory biologic Fasenra (benralizumab) has secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

GSK seeks paediatric indication for Nucala in severe eosinophilic asthma

GlaxoSmithKline (GSK) has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for an additional indication for Nucala (mepolizumab) as an add-on treatment for severe eosinophilic asthma in paediatric patients aged six to 11 years.

BMS secures positive CHMP opinion for Opdivo- Yervoy combo in RCC

Bristol-Myers Squibb (BMS) said that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the approval of Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).

Janssen applies for expanded approval for IMBRUVICA in Europe

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted two Type II variation applications to the European Medicines Agency (EMA) regarding approval for the expanded use of IMBRUVICA (ibrutinib).

FDA grants priority review to Tecentriq combo for triple-negative breast cancer

Roche has secured priority review from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with chemotherapy as the first-line treatment of a form of triple-negative breast cancer (TNBC).

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.