Regulation - Approvals

Cellectar gets FDA rare pediatric disease designation for CLR 131 to treat osteosarcoma

Cellectar Biosciences has secured rare pediatric disease designation (RPDD) from the US Food and Drug Administration (FDA) for its phospholipid drug conjugate (PDC) product candidate CLR 131 to treat rare pediatric cancer, osteosarcoma.

FDA approves Teva’s Ajovy for preventive treatment of migraine

Teva Pharmaceutical Industries has secured approval for its AJOVY (fremanezumab-vfrm) injection from the US Food and Drug Administration (FDA) for the preventive treatment of migraine in adults.

AstraZeneca secures FDA approval for Lumoxiti to treat hairy cell leukaemia

The US Food and Drug Administration (FDA) has approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL).

FDA approves subcutaneous formulation of Actemra to treat systemic juvenile idiopathic arthritis

Genentech, a member of the Roche Group, that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older.

Scottish Medicines Consortium accepts Sanofi’s Dupixent to treat moderate to severe atopic dermatitis

The Scottish Medicines Consortium (SMC) has accepted Dupixent (dupilumab) for restricted use within its existing marketing authorisation.

Merck’s Keytruda combo therapy approved in Europe to treat metastatic NSCLC

Merck has secured approval from the European Commission for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (ALIMTA) and platinum chemotherapy to treat a type of metastatic nonsquamous non-small cell lung cancer (NSCLC).

Teva secures FDA approval for new dosage strength of Cassipa to treat opioid dependence

Teva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) as the maintenance treatment for opioid dependence.

Merck’s Keytruda gets priority review from FDA for Merkel cell carcinoma indication

Merck’s anti-PD-1 therapy Keytruda has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma.

Sanofi gets EC approval for blood-clotting disorder drug Cablivi

Sanofi has secured marketing approval from the European Commission for its Cablivi (caplacizumab) to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP).