Approvals

Pfizer gets EC approval for Vizimpro lung cancer monotherapy

Pfizer has secured approval from the European Commission (EC) for its Vizimpro (dacomitinib) as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Sandoz resubmits biosimilar pegfilgrastim application to US FDA

Sandoz, a Novartis division and a global leader in biosimilars, today announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.

AstraZeneca, Merck secure FDA breakthrough therapy status for selumetinib

AstraZeneca and Merck have secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for selumetinib to treat pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) symptomatic and inoperable plexiform neurofibromas (PN).

Teva’s migraine treatment AJOVY receives EU approval

Teva Pharmaceutical Industries announced that the European Commission (EC) has granted the marketing authorization for AJOVY (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.

FDA approves treatment for patients with non-radiographic axial spondyloarthritis

The US Food and Drug Administration has approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.

AstraZeneca’s Forxiga approved in Japan for type-1 diabetes

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).

Novartis gets FDA nod for multiple sclerosis drug Mayzent

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Mayzent (siponimod) to treat secondary progressive multiple sclerosis (SPMS) with active disease.

AbbVie gets Japanese approval for SKYRIZI to treat plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis

AbbVie has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved SKYRIZI (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.

AstraZeneca’s Forxiga approved in Europe for type-1 diabetes

The European Commission (EC) has approved Forxiga (dapagliflozin) for use in type-1 diabetes (T1D) as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.