Regulation

EC authorizes Clovis Oncology’s Rubraca to treat women with recurrent ovarian cancer

The European Commission (EC) has authorized Clovis Oncology’s Rubraca (rucaparib) for the treatment of women with recurrenr ovarian cancer.

Malvern Panalytical unveils Zetasizer Pro and Ultra systems

Malvern Panalytical has launched its new Zetasizer Pro and Ultra systems, designed to help in decision-making within crucial analytical workflows associated to product development and quality control.

BioMarin’s Palynziq gets FDA approval to treat adults with phenylketonuria

The US Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical’s Palynziq (pegvaliase-pqpz) Injection for the treatment of adults with phenylketonuria (PKU), a serious genetic disease.

FDA approves Dova’s Doptelet for thrombocytopenia in adults with CLD

Dova Pharmaceuticals’ subsidiary AkaRx has secured approval from the US Food and Drug Administration (FDA) for its Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in patients with chronic liver disease (CLD).

Ipsen’s Cabometyx secures approval in Europe for first-line kidney cancer

The European Commission (EC) has approved Ipsen’s Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate or poor- risk advanced renal cell carcinoma (aRCC).

Novartis and Amgen secure FDA approval for migraine drug

Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.

FDA declines to approve Evolus’ DWP-450 for glabellar lines

The US Food and Drug Administration (FDA) has declined to approve Evolus' application seeking approval of DWP-450 to treat glabellar lines in adult patients.

FDA expands approval of Novartis’ Gilenya to treat MS in pediatric patients

Novartis has secured an expanded approval of Gilenya (fingolimod) in the US for the treatment of children and adolescents, in the age group of 10-18 years, with relapsing forms of multiple sclerosis (RMS).

FDA committee recommends approval of Akcea’s FCS drug

The US Food and Drug Administration’s (FDA) division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Akcea Therapeutics' Waylivratm (volanesorsen) for the treatment of familial chylomicronemia syndrome (FCS).