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After the broad approval by European health authorities in June 2013, the company has received a total of nine national phase approvals for Vitaros, including Luxembourg, Belgium, France,

The sanctions against the company relate to part of its promotional activities regarding CASE-J which were inviolation of the ‘Prescription Drugs Promotion Code’ of the JPMA and as

With the approval, Kalbitor is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients 12 years of age and older. The drug

XBiotech is developing next generation natural immune therapies to address serious and drug resistant bacterial infections. The in-licensed technology is reportedly intended to expand and strengthen XBiotech’s position

Leveraging key advantages of AnaptysBio’s SHM-XEL platform, this approach rapidly generates high potency humanized therapeutic antibodies using minimal non-human sequence content. The newly issued US patent is assigned

The final rejection issued today finds the first claim of the reissue application, which is identical to the only claim in the ‘808 Patent, to be indefinite and

Latuda, the antipsychotic agent, has been marketed for the treatment of schizophrenia in Canada by Sunovion Pharmaceuticals Canada, a subsidiary of the US-based Sunovion Pharmaceuticals. The company said

Novaliq claims that CyclASol is the first and only 0.05% clear cyclosporin solution, which is available in multi-dose and preservative free bottles to treat dry eye syndrome. Developed

The MAA validation confirms that the submission is sufficiently complete to start the formal review process. The EMA’s review of the MAA will follow the centralized marketing authorization