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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.

The financing was led by Hillhouse Capital Management and Quan Capital, and included Bay City Capital, Surveyor Capital (a Citadel company), Ping An Ventures, Taiho Ventures LLC, ArrowMark

The FDA and the Company have agreed to meet in-person on January 31, 2019 to discuss this matter. Remoxy is the proposed trade name for a new type