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 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 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.
Circassia Pharmaceuticals announced that the US Food and Drug Administration (FDA) added new data to the TUDORZA PRESSAIR (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.
Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).
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.
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 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 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.
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.
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