FDA Approvals

For an extended time, IBT has consulted with the US FDA on how the company’s planned Phase III study should be designed. IBT announced the...

Impulse Dynamics announces successful implantation of first patient since FDA approval of Optimizer Smart System

FDA Approvals

Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM therapy, announced that the first patient to receive the Optimizer Smart System...

B. Braun launches the First FDA-Approved Heparin Sodium Prefilled Syringe with attached safety needle

FDA Approvals

B. Braun Medical Inc. announced the launch of its Heparin Sodium Injection, USP - the first Heparin 5,000 USP Unit / 0.5 mL prefilled...

U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA

FDA Approvals

Pfizer Inc. announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA„¢ (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab),1 for the treatment...

Halozyme Announces FDA Approval Of Herceptin Hylecta

FDA Approvals

Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, announced that Genentech, a member of the Roche Group, has received approval...

U.S. FDA Approves DARZALEX Split-Dosing Regimen

FDA Approvals

The U.S. FDA gave Janssen Biotech, a Johnson & Johnson company, and their research partner, Copenhagen, Denmark-based Genmab A/S, an approval for their Darzalex...

EC Approves ADCETRIS with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma

FDA Approvals

Takeda Pharmaceutical Company Limited announced that the EC extended the current marketing authorization of ADCETRIS (brentuximab vedotin) to include treatment of adult patients with...

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