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1-15 of 3014 results
Amgen gets FDA approval for heart failure drug Corlanor
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for Corlanor (ivabradine), an oral medication, to reduce the risk of hospitalization for worsening heart failure.
Regulatory Affairs > News
Abbvie's HCV treatment ombitasvir/paritaprevir/ritonavir gets priority review in Japan
By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for AbbVie's investigational product ombitasvir/paritaprevir/ritonavir to treat chronic hepatitis C.
Regulatory Affairs > News
AstraZeneca's cancer drug tremelimumab obtains FDA orphan drug status
By PBR Staff Writer
The US Food and Drug Administration has granted orphan drug designation for AstraZeneca's anti-CTLA-4 monoclonal antibody, tremelimumab, to treat patients with malignant mesothelioma, a rare type of cancer.
Regulatory Affairs > News
Sobi gets Swiss orphan drug designation for Elocta to treat haemophilia A
By PBR Staff Writer
Swedish Orphan Biovitrum (Sobi) has secured orphan drug designation in Switzerland for its long-acting haemophilia drug candidate Elocta (rFVIIIFc) to treat haemophilia A.
Regulatory Affairs > News
ArmaGen's IND application for AGT-181 gets FDA acceptance to treat hurler syndrome
By PBR Staff Writer
US-based biotechnology firm ArmaGen has received acceptance from the US Food and Drug Administration (FDA) for an investigational new drug application (IND) for its second product candidate AGT-181, an investigational enzyme replacement therapy (ERT), to treat Hurler syndrome.
Regulatory Affairs > News
FDA approves Perrigo's ANDA for hydromorphone HCI extended-release tablets
By PBR Staff Writer
The Food and Drug Administration (FDA) has granted final approval for Irish OTC firm Perrigo's abbreviated new drug application (ANDA) for hydromorphone HCI extended-release tablets 8 mg, 12 mg and 16 mg.
Regulatory Affairs > News
Roche gets European approval for Avastin plus chemotherapy to treat advanced cervical cancer
By PBR Staff Writer
Swiss drug-maker Roche has received approval from the the European Commission (EC) for Avastin (bevacizumab) in combination with standard chemotherapy to treat adults with persistent, recurrent or metastatic carcinoma of the cervix.
Regulatory Affairs > News
AbbVie's plaque psoriasis drug Humira gets marketing approval in Europe
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for AbbVie's Humira (adalimumab) to treat children and adolescents with severe chronic plaque psoriasis.
Regulatory Affairs > News
FDA grants orphan drug status for Idera's IMO-8400 to treat diffuse large B-cell lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Idera Pharmaceuticals' IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, to treat diffuse large B-cell lymphoma (DLBCL).
Regulatory Affairs > News
EMA committee recommends Boehringer and Lilly's combination therapy for type 2 diabetes
By PBR Staff Writer
Boehringer Ingelheim and Eli Lilly and Company have received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of a single-pill combination therapy with empagliflozin/metformin hydrochloride (HCl) to treat adults with type 2 diabetes (T2D).
Regulatory Affairs > News
Gilead secures approval in Japan for Sovaldi to treat genotype 2 chronic HCV
By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Gilead Sciences' Sovaldi (sofosbuvir) for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis.
Regulatory Affairs > News
FDA grants orphan drug status for CymaBay's MBX-8025 to treat HoFH
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for CymaBay Therapeutics' MBX-8025, a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, to treat homozygous familial hypercholesterolemia (HoFH), an autosomal genetic disease.
Regulatory Affairs > News
Marinus gets FDA orphan drug status for ganaxolone to treat PCDH19 female epilepsy
By PBR Staff Writer
Marinus Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for ganaxolone, a synthetic analog of the endogenous neurosteroid allopregnanolone, to treat protocadherin 19 gene (PCDH19) female epilepsy.
Regulatory Affairs > News
Regulus' RG-012 gets orphan medicinal product designation in Europe to treat alport syndrome
By PBR Staff Writer
The European Commission has granted orphan medicinal product designation for US-based biopharmaceutical firm Regulus Therapeutics' RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 (miR-21) to treat Alport syndrome.
Regulatory Affairs > News
Agios gets FDA orphan drug status for AG-348 to treat pyruvate kinase deficiency
By PBR Staff Writer
Agios Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational medicine AG-348 to treat pyruvate kinase (PK) deficiency, a rare form of hemolytic anemia.
Regulatory Affairs > News
1-15 of 3014 results