The end of the transition period is imminent. How can clinical trial sponsors and CROs ease the transition to CTIS? Soon, the one-year transition period …
Brexit has provided several challenges to the pharmaceutical industry that required robust actions and swift resolution in order to remain in compliance following the end …
First therapeutic to receive positive CHMP opinion for treatment of a rare blood disorder called acquired thrombotic thrombocytopenic purpura The European Medicines Agency’s Committee for …
WuXi STA enables Ascletis to receive NDA Approval from China FDA for Ganovo® STA Pharmaceutical Co., Ltd. (WuXi STA), a subsidiary of WuXi AppTec, announces …
First filing made for a triple therapy for chronic obstructive pulmonary disease offered in a single inhaler. Chronic obstructive pulmonary disease (COPD) affects over five …
DARZALEX (daratumumab) approved by U.S. FDA in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are …
Invivoscribe Technologies, Inc. announced today that they have submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) …
The FDA has approved Novartis’ Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma, as detected by …
Outline planning permission application for expansion of the Hoeford Point site now approved. Wickham Laboratories Holdings, owner of Wickham Laboratories Ltd, today announces approval of …
TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop …
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