Approvals

uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe

uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).

EMA’s CHMP recommends approval for Kevzara for rheumatoid arthritis

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.

Biosimilars to rituximab, etanercept recommended for approval in Europe

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of both Sandoz' biosimilars rituximab and etanercept to treat the same indications as their respective reference medicines.

Genentech’s ranibizumab injection approved by FDA for diabetic retinopathy

The US Food and Drug Administration (FDA) has approved Genentech’s Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy.

FDA approves supplemental applications of two hepatitis C drugs for pediatric patients

Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for supplemental indications of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for chronic hepatitis C virus (HCV) infection treatment in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.

EU approves Novartis Tafinlar + Mekinist combination for NSCLC treatment

Novartis’ drug combination of Tafinlar (dabrafenib) and Mekinist (trametinib) has been approved by the European Commission for the treatment of patients having BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).

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.