Approvals

Roche’s lung cancer drug Alecensa secures approval in China

Roche has secured marketing authorization from the China National Drug Administration (CNDA) for its Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive and advanced non-small cell lung cancer (NSCLC).

FDA approves Bristol-Myers’ Opdivo to treat metastatic SCLC

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's (BMS) Opdivo as the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.

Merck, Eisai win FDA approval for Lenvima to treat unresectable HCC

Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for kinase inhibitor Lenvima (lenvatinib) as the first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).

FDA approves Sun Pharma’s CEQUA for treatment of dry eye disease

Sun Pharmaceutical Industries has secured approval for its dry eye disease treatment CEQUA (cyclosporine ophthalmic solution) 0.09%, from the US Food and Drug Administration (FDA).

Onspira’s bronchiolitis obliterans treatment secures FDA orphan drug status

Onspira Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its investigational product, OSP-101, to treat Bronchiolitis Obliterans (BO).

Roche’s Xolair gets FDA breakthrough status for food allergies

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche's Xolair (omalizumab) for the prevention of severe allergic reactions after accidental exposure to one or more foods in people with allergies.

FDA approves Alnylam’s Onpattro to treat polyneuropathy of hATTR amyloidosis

Alnylam Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its RNA interference (RNAi) therapeutic, Onpattro (patisiran) lipid complex injection, to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

BioCryst’s HAE drug BCX7353 gets FDA fast track designation

BioCryst Pharmaceuticals’ plasma kallikrein inhibitor BCX7353 has been given fast track designation by the US Food and Drug Administration (FDA) for the prevention of angioedema attacks in patients having hereditary angioedema (HAE).

EMA grants orphan designation to selumetinib to treat neurofibromatosis type 1

The European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor which is being developed by AstraZeneca and Merck to treat neurofibromatosis type 1 (NF1).