Approvals

FDA panel recommends approval of Rituxan biosimilar

The US Food and Drug Administration’s (FDA) advisory committee has recommended approval of Celltrion and Teva Pharmaceutical’s biosimilar of Roche’s blood cancer drug Rituxan (rituximab).

FDA expands use of Merck’s Gardasil 9 HPV vaccine up to age 45

The US Food and Drug Administration (FDA) has approved Merck’s human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, to be used as treatment for women and men aged from 27 years to 45 years.

Roche gets FDA approval for Hemlibra for haemophilia A without factor VIII inhibitors

Roche has secured approval from the US Food and Drug Administration (FDA) for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients of all ages having haemophilia A without factor VIII inhibitors.

Regeneron, Sanofi secure FDA nod for skin cancer drug Libtayo

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.

ACCC clears merger of generic pharmaceutical firms Arrow and Apotex

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 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.