Regulation - Approvals

Novartis gets breakthrough therapy status for sickle cell disease treatment crizanlizumab

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for crizanlizumab (SEG101) to prevent vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).

BMS’ Sprycel secures FDA approval to treat pediatric Ph+ ALL

The US Food and Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients, aged one year or more.

US FDA approves Sanofi’s new pediatric vaccine

The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.

FDA accepts Kala Pharmaceuticals’ NDA for KPI-121 0.25%

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate.

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).