Regulatory Affairs

Regulatory Affairs News

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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
FDA rejects Sandoz’s BLA for proposed biosimilar rituximab
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Sandoz’s biologics licensing application (BLA) for its proposed biosimilar rituximab.
Regulatory Affairs > News
FDA expands approval of Novartis’ Kymriah CAR-T therapy
By PBR Staff Writer
Novartis has secured a second approval for Kymriah (tisagenlecleucel) in the US for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma who had more than two lines of systemic therapy.
Regulatory Affairs > News
FDA grants priority review for Keytruda, chemotherapy combination in NSCLC
Merck said that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy Keytruda based on the results of the phase 3 KEYNOTE-189 trial.
Regulatory Affairs > News
AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tagrisso (osimertinib) to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA
By PBR Staff Writer
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Regulatory Affairs > News
ValiRx secures EU patent grant for VAL201 prostate cancer treatment
By PBR Staff Writer
ValiRx has secured a patent grant from the European Union (EU) for its prostate cancer treatment, VAL201, which is currently under clinical studies.
Regulatory Affairs > News
FDA expands GSK’s Trelegy Ellipta indication in COPD
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.
Regulatory Affairs > News
Pfizer biosimilar of Roche's cancer drug fails to get FDA approval
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to approve Pfizer’s proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab) and asked for more technical information.
Regulatory Affairs > News
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