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Regulatory Affairs

FDA, European Commission grant orphan drug status to Boehringer's volasertib By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Commission (EC) have granted orphan drug designation for Germany-based Boehringer Ingelheim's volasertib to treat patients with acute myeloid leukaemia (AML), an aggressive cancer of the bone marrow and blood.
Regulatory Affairs > News
FDA accepts NDA for combination drug to treat type 2 diabetes By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for Boehringer Ingelheim and Eli Lilly's investigational combination tablet of empagliflozin and linagliptin to treat adults with type 2 diabetes (T2D).
Regulatory Affairs > News FDA extends market exclusivity of BioMarin's Phenylketonuria drug Kuvan for six months By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted BioMarin Pharmaceutical's Kuvan (sapropterin dihydrochloride) Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension.
Regulatory Affairs > News
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BMS files NDA to FDA for combination tablet to treat HIV-1
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, for the treatment of HIV-1 infection.
Regulatory Affairs > News
Trinidad & Tobago Ministry of Health approves Janssen's prostate cancer drug Zytiga
By PBR Staff Writer
The Chemistry, Food & Drugs Division of the Trinidad & Tobago Ministry of Health has approved the introduction of Janssen's Abiraterone Acetate in the country for the treatment of patients with metastatic castration-resistant prostate cancer.
Regulatory Affairs > News
FDA grants breakthrough therapy status for Celladon' heart failure treatment Mydicar
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Celladon's lead product candidate, Mydicar, for reducing hospitalisations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative.
Regulatory Affairs > News
Boehringer's Pradaxa gets FDA approval for DVT, PE treatment
By PBR Staff Writer
Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).
Regulatory Affairs > News
SHL in Korea: Insight into the Changing World of Auto Injectors
The global injectable drug delivery device technologies market was valued at approximately $10.2bn in 2012 and is expected to grow at a CAGR rate of 11% to $17.2bn by 2017.
Regulatory Affairs > Press Releases
Bristol-Myers files NDAs to FDA for daclatasvir and asunaprevir to treat hepatitis C
By PBR Staff Writer
US-based biopharmaceutical firm Bristol-Myers Squibb (BMS) has submitted new drug applications (NDAs) to the US Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor, indicated for the treatment of Hepatitis C.
Regulatory Affairs > News
Apricus gets approval for erectile dysfunction drug Vitaros in Luxembourg
By PBR Staff Writer
Apricus Biosciences has secured national phase approval from the Ministry of Health of Luxembourg for Vitaros, a topical on-demand treatment for erectile dysfunction (ED).
Regulatory Affairs > News
FDA approves expanded use of Dyax's HAE drug Kalbitor
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expansion of the indication for Dyax's Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older.
Regulatory Affairs > News
Dainippon's Latuda gets approval in Canada to treat bipolar depression
By PBR Staff Writer
Dainippon Sumitomo Pharma (DSP) has received approval from Health Canada for use of Latuda (lurasidone HCl) as monotherapy or as adjunctive therapy with lithium or valproate to treat depressive episodes associated with bipolar I disorder.
Regulatory Affairs > News
EMA validates Keryx's marketing authorization application for Zerenex
By PBR Staff Writer
The European Medicines Agency (EMA) has validated Keryx Biopharmaceuticals' marketing authorization application (MAA) which seeks the approval of Zerenex (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease (CKD), including dialysis- and non-dialysis-dependent CKD.
Regulatory Affairs > News
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