Approvals

FDA approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) 80mg once-daily tablets to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases

Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.

FDA approves Serenity’s Noctiva to treat nocturia

Serenity Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Noctiva (desmopressin acetate) to treat frequent urination at night due to overproduction of urine.

UK’s NICE backs use of Intercept’s Ocaliva for primary biliary cholangitis

Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) has been approved by the UK's National Institute for Health and Care Excellence (NICE) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland.

FDA grants priority review to Enasidenib for IDH2-Mutant AML

The US Food and Drug Administration (FDA) has accepted under priority review Celgene's new drug application (NDA) seeking approval of enasidenib to treat patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation.

EMA’s CHMP recommends approval of Novartis’ Tafinlar in combination with Mekinist

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval to the European Medicines Agency (EMA) of Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) as therapy for advanced or metastatic non-small cell lung cancer (NSCLC) patients whose tumors express the BRAF V600 mutation.

Valeant gets FDA approval for SILIQ to treat moderate-to-severe plaque psoriasis

The US Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals International's Biologics License Application (BLA) for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.

FDA plans to not to hold advisory committee meeting for Portola’s betrixaban NDA

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) is not planning to hold an Advisory Committee meeting for Portola Pharmaceuticals' New Drug Application (NDA) for betrixaban.

FDA accepts Intellipharmaceutics’ NDA for Rexista to treat moderate to severe pain

The US Food and Drug Administration has accepted for filing of Intellipharmaceutics International’s New Drug Application ("NDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.