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EMA and FDA aim to slash Gaucher disease R&D costs pharmaphorum
July 06, 2017
US and European regulators want to promote the development of drugs for paediatric Gaucher disease, moves which could also apply to other rare diseases in children.
EMA and FDA propose new approach for Gaucher disease drug development pharmaceutical-technology
July 06, 2017
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have proposed new approaches to the development of medicine to treat Gaucher disease.
FDA announces a strategic plan to eliminate orphan designation backlog biospectrumasia
July 05, 2017
The agency intends to communicate around the successful elimination of the backlog by mid-September.
Wockhardt receives US FDA approval for Olopatadine HCI financialexpress
July 04, 2017
Olopatadine HCI, eye drop to treat ophthalmic allergies, is a generic version of Patanol
FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer cphi-online
July 04, 2017
First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.
Zydus Cadila gets US FDA nod to market anti-obesity drug financialexpress
July 03, 2017
The drug will be produced at the group’s formulations manufacturing facility at Moraiya in Ahmedabad
Rise in product recalls prompts FDA to warn of possible BCC contamination europeanpharmaceuticalreview
July 03, 2017
The US Food and Drug Administration (FDA) has advised manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC) contamination.
Data Analysis of Relevant Warning Letters of FDA on Computer System en-cphi.cn
June 30, 2017
As is known to all, FDA, one of the strictest drug administration agencies in the world, mainly take charge of safeguarding the health and safety of consumers based on federal food, drug, cosmetics laws and other laws.
FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder firstwordpharma
June 30, 2017
FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder
FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer firstwordpharma
June 30, 2017
FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer

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