Regulatory Affairs

Regulatory Affairs News

View news from other Pharmaceutical sectors:
16-30 of 3690 results
BioMarin’s Palynziq gets FDA approval to treat adults with phenylketonuria
By PBR Staff Writer
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.
Regulatory Affairs > News
FDA declines to approve Cosmo’s NDA for Methylene Blue MMX
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Cosmo Pharmaceuticals, saying that it cannot approve the latter’s Methylene Blue MMX as a visualization aid to increase detection of lesions in the colon.
Regulatory Affairs > News
FDA to review Zynquista as potential treatment for type 1 diabetes
The US Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin).
Regulatory Affairs > News
ViiV Healthcare gets EC approval for Juluca to treat HIV-1 infection
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has secured marketing approval from the European Commission (EC) for Juluca (dolutegravir 50mg/rilpivirine 25mg) to treat human immunodeficiency virus type 1 (HIV-1) infection.
Regulatory Affairs > News
FDA approves Dova’s Doptelet for thrombocytopenia in adults with CLD
By PBR Staff Writer
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).
Regulatory Affairs > News
FDA approves AstraZeneca’s Lokelma to treat hyperkalemia in adults
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
Regulatory Affairs > News
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).
Regulatory Affairs > News
Novartis and Amgen secure FDA approval for migraine drug
By PBR Staff Writer
Novartis and Amgen have secured approval from the US Food and Drug Administration (FDA) for Aimovig (erenumab), a treatment developed specifically for migraine prevention.
Regulatory Affairs > News
FDA declines to approve Evolus' DWP-450 for glabellar lines
By PBR Staff Writer
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.
Regulatory Affairs > News
FDA approves Pfizer’s epoetin alfa biosimilar Retacrit to treat anemia
By PBR Staff Writer
Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s anemia drug Epogen/Procrit (epoetin alfa), has been approved by the US Food and Drug Administration (FDA) for all indications of the reference product.
Regulatory Affairs > News
FDA expands approval of Novartis’ Gilenya to treat MS in pediatric patients
By PBR Staff Writer
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).
Regulatory Affairs > News
FDA turns down Lipocine’s application for oral testosterone product Tlando
By PBR Staff Writer
The US Food and Drug Administration (FDA) has refused to approve Lipocine's Tlando, an oral testosterone product candidate for testosterone replacement therapy (TRT).
Regulatory Affairs > News
EMA approves Lynparza tablets to treat platinum-sensitive relapsed ovarian cancer
By PBR Staff Writer
AstraZeneca and Merck have secured approval from the European Medicines Agency (EMA) for Lynparza tablets to treat patients with platinum-sensitive relapsed ovarian cancer.
Regulatory Affairs > News
FDA approves updated label of Relypsa’s Veltassa hyperkalemia drug
The US Food and Drug Administration (FDA) has approved Relypsa’ supplemental new drug application (sNDA) for Veltassa (patiromer) for oral suspension in the treatment of hyperkalemia, or elevated blood potassium levels.
Regulatory Affairs > News
Novartis’ Tafinlar/Mekinist combo gets FDA nod for anaplastic thyroid cancer
By PBR Staff Writer
Novartis Pharmaceuticals has secured approval from the US Food and Drug Administration for its Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy to treat anaplastic thyroid cancer (ATC).
Regulatory Affairs > News
16-30 of 3690 results