Approvals

FDA approves Ultomiris for use in treatment of rare blood disease

The US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab) injection for use in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

AstraZeneca’s partner FibroGen gets approval in China for CKD treatment roxadustat

AstraZeneca’s partner FibroGen China has secured marketing approval from the China’s National Medical Products Administration (NMPA) for roxadustat to treat anemia in chronic kidney disease (CKD) patients on dialysis.

Teva, Celltrion get FDA nod for Roche’s breast cancer drug biosimilar

Teva Pharmaceutical Industries, along with Celltrion, has secured approval from the US Food and Drug Administration (FDA) for breast cancer drug Herzuma (trastuzumab-pkrb), a biosimilar to Roche’s Herceptin.

Novartis gets EC approval for self-administration of Xolair across all indications

Novartis has secured approval from the European Commission (EC) for Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.

Novartis’ Gilenya gets approval in Europe to treat children and adolescents with MS

Novartis has secured approval from the European Commission (EC) for its Gilenya (fingolimod) to treat children and adolescents, aged between 10 and 17 years, with relapsing-remitting forms of multiple sclerosis (RRMS).

Teva, Celltrion get FDA nod for biosimilar to Roche’s cancer drug Rituxan

Teva Pharmaceutical and Celltrion have secured approval from the US Food and Drug Administration (FDA) for Truxima (rituximab-abbs), a biosimilar to Roche’s cancer drug Rituxan (rituximab), for three non-Hodgkin’s lymphoma indications.

Mundipharma’s Neulasta biosimilar Pelmeg secures approval in Europe

The Mundipharma network of independent associated companies has secured approval from the European Commission (EC) for its Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy for chemotherapy.

Camurus gets EU nod for weekly and monthly Buvidal for opioid dependence

The European Commission (EC) has approved Camurus’ weekly and monthly Buvidal (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age.

Pfizer’s Daurismo gets FDA approval to treat elderly adults with AML

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Daurismo (glasdegib) to treat adult patients with newly-diagnosed acute myeloid leukemia (AML) for whom intensive chemotherapy is not an option.