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1-15 of 3526 results
Merck, Pfizer get EC approval for skin cancer drug Bavencio
By PBR Staff Writer
Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.
Regulatory Affairs > News
Roche gets EC nod for Gazyvaro to treat advanced follicular lymphoma
By PBR Staff Writer
Roche has secured approval from the European Commission (EC) for its Gazyvaro (obinutuzumab) in combination with chemotherapy for the treatment for previously untreated advanced follicular lymphoma.
Regulatory Affairs > News
Novartis’ Rydapt approved in Europe for AML and rare blood disorders
By PBR Staff Writer
Novartis’ cancer drug Rydapt (midostaurin) has been approved by the European Commission (EC) for a mutated form of acute myeloid leukemia (AML) and certain rare blood disorders.
Regulatory Affairs > News
Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery
Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
Regulatory Affairs > News
Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea
Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Regulatory Affairs > News
GSK, Innoviva get FDA nod for COPD treatment Trelegy Ellipta
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva have secured approval from the US Food and Drug Administration (FDA) for once-daily and single inhaler triple therapy, Trelegy Ellipta, to treat patients with chronic obstructive pulmonary disease (COPD).
Regulatory Affairs > News
FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment
The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.
Regulatory Affairs > News
Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
Regulatory Affairs > News
FDA approves biosimilar of Avastin to treat five types of cancer
By PBR Staff Writer
Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Mvasi (bevacizumab-awwb), a biosimilar to Roche's Avastin, to treat five types of cancer.
Regulatory Affairs > News
Regeneron, Sanofi get FDA breakthrough therapy status for skin cancer drug cemiplimab
By PBR Staff Writer
Regeneron Pharmaceuticals and Sanofi have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for cemiplimab (REGN2810) to treat advanced cutaneous squamous cell carcinoma (CSCC).
Regulatory Affairs > News
Novo Nordisk settles US suit over diabetes drug Victoza
By PBR Staff Writer
Novo Nordisk has agreed to pay $58.65m to settle charges relating to the marketing of its type 2 diabetes drug Victoza (liraglutide) in the US.
Regulatory Affairs > News
Deciphera gets FDA orphan drug designation for DCC-2618 to treat glioblastoma multiforme and anaplastic astrocytoma
Deciphera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, for the treatment of glioblastoma multiforme and anaplastic astrocytoma.
Regulatory Affairs > News
EC approves Merck’s Keytruda to treat urothelial carcinoma
By PBR Staff Writer
Merck has secured approval from the European Commission (EC) for its Keytruda (pembrolizumab) to treat certain patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer).
Regulatory Affairs > News
Oragenics doses first patient in phase 2 clinical trial of AG013 for oral mucositis
Oragenics has announced that the first patient has been dosed in its Phase 2 clinical trial of AG013 for the treatment of oral mucositis (OM).
Regulatory Affairs > News
Sunovion seeks FDA approval for dasotraline to treat patients with ADHD
Sunovion Pharmaceuticals announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline, a novel investigational, dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).
Regulatory Affairs > News
1-15 of 3526 results