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1-15 of 3044 results
Otsuka's Jinarc gets European marketing authorization to treat ADPKD
By PBR Staff Writer
Japan-based Otsuka Pharmaceutical has received marketing authorization from the European Commission for Jinarc (tolvaptan) to treat autosomal dominant polycystic kidney disease (ADPKD) in adults.
Regulatory Affairs > News
FDA receives Aurobindo request to use dolutegravir for HIV treatment
By PBR Staff Writer
ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative (CHAI) announced that Aurobindo Pharma has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for Tentative Approval, to the Food and Drug Administration (FDA), for the treatment of HIV.
Regulatory Affairs > News
Synageva submits NDA in Japan for Kanuma to treat LAL deficiency
By PBR Staff Writer
US-based biopharmaceutical firm Synageva BioPharma has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for Kanuma (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL Deficiency).
Regulatory Affairs > News
ZS Pharma files NDA to US FDA for ZS-9 to treat hyperkalemia
By PBR Staff Writer
US-based biopharmaceutical firm ZS Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for its lead therapeutic candidate, ZS-9 (sodium zirconium cyclosilicate), to treat hyperkalemia.
Regulatory Affairs > News
FDA grants orphan drug status for Cerulean Pharma's ovarian cancer drug CRLX101
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Cerulean Pharma's nanoparticle-drug conjugate (NDC), CRLX101, for the treatment of ovarian cancer.
Regulatory Affairs > News
United Therapeutics' Unituxin gets EMA marketing authorization to treat neuroblastoma
By PBR Staff Writer
United Therapeutics Europe has received marketing authorisation from the European Medicines Agency (EMA) for Unituxin (dinutuximab) to treat high-risk neuroblastoma, a type of cancer that most often occurs in young children.
Regulatory Affairs > News
PlasmaTech's lead product candidates get FDA orphan drug and rare pediatric disease designations
PlasmaTech Biopharmaceuticals (PTBI), a biopharmaceutical company focused on gene therapy and plasma-based products for severe and life- threatening rare diseases announced that the US Food and Drug Administration (FDA) had granted both Orphan Drug Designation and Rare Pediatric Disease Designation for both of PlasmaTech Biopharmaceuticals' lead product candidates for the treatment of Sanfilippo Syndromes A and B.
Regulatory Affairs > News
Bristol-Myers gets amended FDA breakthrough therapy status for daclatasvir-based HCV regimen
By PBR Staff Writer
The US Food and Drug Administration (FDA) has amended a previously granted breakthrough therapy designation for Bristol-Myers Squibb's investigational daclatasvir and sofosbuvir combination to treat patients with hepatitis C (HCV).
Regulatory Affairs > News
FDA grants orphan drug status for Alnylam's Revusiran to treat TTR-mediated amyloidosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation to Alnylam Pharmaceuticals' investigational RNAi therapeutic, revusiran, to treat transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis).
Regulatory Affairs > News
Sarepta to submit rolling NDA for eteplirsen to treat DMD
By PBR Staff Writer
US-based biopharmaceutical firm Sarepta Therapeutics has held a pre-new drug application (NDA) meeting with the US Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, to treat duchenne muscular dystrophy (DMD).
Regulatory Affairs > News
Boehringer gets acceptance in Scotland for Trajenta-insulin combination to treat T2D
By PBR Staff Writer
The Scottish Medicines Consortium (SMC) has accepted Boehringer Ingelheim's Trajenta (linagliptin) in combination with insulin to treat adults with type 2 diabetes (T2D) to improve glycaemic control.
Regulatory Affairs > News
Therabron's CG100 gets EMA orphan drug status to prevent bronchopulmonary dysplasia
By PBR Staff Writer
US-based biotechnology firm Therabron Therapeutics has received orphan drug designation from the European Medicines Agency (EMA) for its lead product candidate, CG100, for the prevention of bronchopulmonary dysplasia (BPD).
Regulatory Affairs > News
Fibrocell gets FDA rare pediatric disease designation for FCX-007 to treat RDEB
Fibrocell Science (FCSC), an autologous cell and gene therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, announced that the US Food and Drug Administration (FDA) has granted rare pediatric disease designation for Fibrocell's lead orphan gene-therapy drug candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Regulatory Affairs > News
FDA grants fast track status for Merck's pancreatic cancer drug evofosfamide
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Merck's evofosfamide to treat patients living with advanced pancreatic cancer.
Regulatory Affairs > News
Hemispherx Biopharma gets EMA orphan medicine designation for Ampligen to treat Ebola Virus Disease
Hemispherx Biopharma has announced that its European subsidiary, Hemispherx Biopharma Europe, received formal notification from the European Commission [EU/3/15/1480-EMA/OD/310/14] approving its Orphan Medicinal Product Application for Ampligen(R), an experimental therapeutic, to treat Ebola Virus Disease (EVD).
Regulatory Affairs > News
1-15 of 3044 results