Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for their Libtayo (cemiplimab-rwlc) to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
The Australian Competition and Consumer Commission (ACCC) has decided not to oppose the merger of generic pharmaceutical companies Arrow and Apotex after finding that the transaction would not reduce competition in any market.
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.
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.
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).
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.
The Scottish Medicines Consortium (SMC) has accepted Dupixent (dupilumab) for restricted use within its existing marketing authorisation.
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 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 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.
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