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FDA approves Bristol-Myers Squibb’s Orencia for active psoriatic arthritis
pharmaceutical-technology
July 11, 2017
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Orencia for the treatment of adult?patients with active psoriatic arthritis (PsA).
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Novartis combination targeted therapy receives FDA approval
europeanpharmaceuticalreview
July 10, 2017
The FDA has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer.
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NDA of FDA in 2017 Q2: Total Number of New Drugs Approved Having Surpassed That of the 2016
en-cphi.cn
July 07, 2017
With a half of 2017 past, unlike the downturn experienced in 2016, the new drug approval of FDA in 2017 can be called sailing with the wind...
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EMA and FDA harmonise over development of Gaucher drugs
pharmafile
July 06, 2017
The EMA and the FDA have announced that they have developed a joint proposal to promote more efficient means of bringing through treatments for Gaucher disease.
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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.
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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.
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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.
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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
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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.
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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
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