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Regulatory Affairs

Audentes gets orphan status for At001 to treat XLMTM in US and Europe By PBR Staff Writer
US-based Audentes Therapeutics has received orphan drug designation from the FDA and the European Medicines Agency (EMA) for its AT001, an investigational product being developed to treat X-Linked Myotubular Myopathy (XLMTM), a rare, severe, inherited disorder.
Regulatory Affairs > News
FDA, EMA accept regulatory applications for Boehringer's Giotrif/Gilotrif to treat advanced squamous cell carcinoma of lung Boehringer Ingelheim announced that both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy.
Regulatory Affairs > News FDA gets orphan drug designation for Tocagen's Toca 511 & Toca FC to treat glioblastoma Tocagen, a clinical-stage immuno-oncology company, announced that the US Food and Drug Administration has granted orphan drug designation to the company's lead immuno-oncology product candidate, Toca 511 & Toca FC, for the treatment of glioblastoma.
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Santen gets approval of TAPROS in China to treat open-angle glaucoma and ocular hypertension
Santen Pharmaceutical announced that it received an import drug license of TAPROS Ophthalmic Solution 0.0015% for the treatment of open-angle glaucoma and ocular hypertension in China on July 27, 2015 with required procedures completed on August 21st.
Regulatory Affairs > News
Amgen submits NDA for new intravenous calcimimetic etelcalcetide to treat SHPT in CKD patients
By PBR Staff Writer
Amgen has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for etelcalcetide (formerly AMG 416) to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis.
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FDA expands use of Novartis' Promacta to include treatment for chronic ITP
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded use for Novartis' Promacta (eltrombopag) to include children one year of age and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
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Corbus gets FDA fast track status for Resunab to treat systemic sclerosis
By PBR Staff Writer
Corbus Pharmaceuticals Holdings has secured fast track status from the US Food and Drug Administration (FDA) for Resunab to treat systemic sclerosis (scleroderma), a serious, life-threatening autoimmune disease.
Regulatory Affairs > News
FDA grants rare pediatric disease designation for BioMarin's drisapersen to treat DMD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted rare pediatric disease designation for BioMarin Pharmaceutical's drisapersen, a potential treatment for patients with Duchenne Muscular Dystrophy (DMD) who are amenable to exon 51 skipping treatment.
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Sobi, Menarini announce Australian approval for Kineret in Juvenile Idiopathic Arthritis
By PBR Staff Writer
Swedish Orphan Biovitrum (Sobi) along with its partner, A. Menarini Australia has announced the receipt of marketing authorisation for Kineret (anakinra) in Australia.
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Health Canada approves Alexion's Strensiq to treat patients with hypophosphatasia
Alexion Pharma Canada, a subsidiary of Alexion Pharmaceuticals (ALXN), announced that Health Canada has approved Strensiq (asfotase alfa) as enzyme replacement therapy for patients with confirmed diagnosis of paediatric-onset hypophosphatasia (HPP).
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Veloxis’ Envarsus XR gets orphan drug status for kidney transplant rejection prophylaxis
By PBR Staff Writer
Denmark-based Veloxis Pharmaceuticals has received orphan drug status by the US Food and Drug Administration (FDA) for its Envarsus XR (tacrolimus extended-release tablets).
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EC grants marketing authorisation to Unituxin (dinutuximab) for paediatric high-risk neuroblastoma
United Therapeutics Corporation has announced that the European Commission (EC) has granted Marketing Authorisation for Unituxin™ (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
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FDA accepts sNDA for review of Takeda and Lundbeck's brintellix in MDD patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Takeda and Lundbeck's Brintellix (vortioxetine) on certain aspects of cognitive function in adults with major depressive disorder (MDD) to the current product label.
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