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The EC’s approval is conditional on Takeda and Shire fulfilling commitments given to the EC in connection with the clearance. Specifically, in relation to the future potential overlap

LEO Pharma research vice president Thorsten Thormann said: “We are very excited about the partnership with PellePharm, who are pioneers in Gorlin Syndrome and experts in rare skin

This decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result

In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo. With the QDIP designation, intended for antibacterial drugs that treat serious

The submission is supported by a paediatric open-label study conducted in children aged six to 11 years that investigated pharmacokinetics, pharmacodynamics and long-term safety. Mepolizumab, a humanised anti-IL5

Nexus Pharmaceuticals chief commercial officer Omair Ahmed said: “The approval of generic Arsenic Trioxide injection continues to show Nexus’s commitment in providing access to affordable critical-need generic injectables.

This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Bristol-Myers Squibb melanoma and genitourinary

One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from

Study results, published online in Cell Reports, showed that DMAbs were expressed over a wide window of time and offered complete and long-term protection against lethal virus challenges.