FDA Approvals

Nucala receives EU approval for self administration by patients with severe eosinophilic asthma

9th August 2019

GlaxoSmithKline announced that the European Commission has granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled...

IBM KPMG Merck and Walmart to collaborate as part of FDA s program to evaluate the use of blockchain to protect pharmaceutical product integrity

by Content Team

24th June 2019

blockchain to protect pharmaceutical product integrity

IBM and Walmart announced that the companies have been selected by the US FDA to be included in a program...

FDA approves Celgenes R2 for two types of indolent lymphoma

by Content Team

30th May 2019

Celgene has announced that the US FDA has approved Revlimid (lenalidomide) in combination with rituximab (R2) for patients with previously...

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

by Content Team

13th March 2019

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

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

Halozyme Announces FDA Approval Of Herceptin Hylecta

by Content Team

4th March 2019

Halozyme Announces FDA Approval Of Herceptin Hylecta

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

U.S. FDA Approves DARZALEX Split-Dosing Regimen

by Content Team

13th February 2019

U.S. FDA Approves DARZALEX Split-Dosing Regimen

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

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

by Content Team

12th February 2019

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

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

EC Approves Bristol-Myers Squibb’s Sprycel in Combination with Chemotherapy for Treatment of Pediatric Patients

by Content Team

12th February 2019

EC Approves Bristol-Myers Squibb’s Sprycel in Combination with Chemotherapy for Treatment of Pediatric Patients

Bristol-Myers Squibb Co. announced that the EC has approved Sprycel in combination with chemotherapy for the treatment of pediatric patients...

US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

by Content Team

8th February 2019

US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US FDA has granted Breakthrough Therapy Designation...