News

Cardiogenesis has submitted an IDE (Investigational Device Exemption) to the FDA to initiate a safety and feasibility trial for its Phoenix System in patients with refractory angina. The

Millennium has reported that the FDA has approved Takeda Oncology’s (Takeda) supplemental new drug application (sNDA) for Velcade, which expands the label to include long-term (median follow-up 36.7

BioInvent International (BioInvent) has treated first patient in an open, dose-escalation Phase I study of antibody BI-505 for patients with advanced multiple myeloma. The Phase I study will

The Medicines Company has filed lawsuits against Teva Parenteral Medicines (Teva), Pliva Hrvatska and related entities in the US District Court for the District of Delaware alleging patent

Cepheid has been granted Emergency Use Authorization (EUA) from the FDA for its ‘Xpert’ Flu A Panel test. The test, which runs on GeneXpert System, identifies the 2009

The FDA has accepted to review the New Drug Application (NDA) seeking marketing approval for the investigational drug, Retigabine developed by Valeant Pharmaceuticals International (Valeant). Retigabine is a

Biodel has submitted a new drug application (NDA) to the FDA for clearance to market VIAject as a treatment for diabetes. VIAject is Biodel’s proprietary formulation of recombinant

Anika Therapeutics (Anika) has acquired Fidia Advanced Biopolymers, (FAB), a wholly-owned subsidiary of Fidia Farmaceutici. Anika will develop its own direct US sales capability to capture higher margins

D-Pharm has reported enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI) at the Wolfson Medical Center, Israel. The MACSI trial