Page 12 - Project Orbis News Today

Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring

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Share this article Share this article SILVER SPRING, Md., May 21, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today. "Advances in preci...

FDA approves Rybrevant for treating subset of non-small cell lung cancer Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today. Advances in precision oncology co...

AZ Tagrisso first to win MHRA approval under Project Orbis 7th May 2021 AstraZenecas Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UKs Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis. Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland, Singapore, Brazil and the UK as other participants, which offers a framework for concurrent su...

UK medicines regulator issues its first authorisation under Project Orbis UK medicines regulator issues its first authorisation under Project Orbis for Osimertinib (Tagrisso), a post-surgery treatment for lung cancer. From: 7 May 2021 A post-surgery treatment for lung cancer will be the first to receive an authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis - only four months after the agency joined the scheme in January 2021. Osimertinib ...

AstraZeneca: ASTRAZENECA SECURES LICENSE EXTENSION AND EARLY NHS ENGLAND ACCESS TO TAGRISSO - (osimertinib) FOR PATIENTS WITH COMPLETELY RESECTED EARLY-STAGE EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER 1 AstraZeneca, NHS England and NICE have reached an agreement to enable early access to osimertinib for patients with this type of cancer, while NICE undertakes its appraisal. Patients with early-stage lung cancer are treated with the intention of cure; however, many relapse because treatm...

Kadmon Provides Business Update and Reports First Quarter 2021 Financial Results ACCESSWIRE 07 May 2021, 06:19 GMT+10 NEW YORK, NY / ACCESSWIRE / May 6, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today provided a business update and reported financial and operational results for the first quarter of 2021. We continue to ramp up commercial launch preparation activities for belumosudil in anticipation of the PDUFA goal date of August 30, 2021. Labeling discussions with the FDA are progressing and...

Kadmon Holdings, Inc.: Kadmon Provides Business Update and Reports First Quarter 2021 Financial Results NEW YORK, NY / ACCESSWIRE / May 6, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today provided a business update and reported financial and operational results for the first quarter of 2021. "We continue to ramp up commercial launch preparation activities for belumosudil in anticipation of the PDUFA goal date of August 30, 2021. Labeling discussions with the FDA are progressing and we believe t...

(0) NEW YORK, NY / ACCESSWIRE / April 21, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced the publication of results from KD025-208, the Phase 2a clinical trial of belumosudil (KD025) for chronic graft-versus-host disease (cGVHD). The results were published in the Journal of Clinical Oncology. A New Drug Application (NDA) for belumosudil is currently under Priority Review by the U.S Food and Drug Administration (FDA) for the treatment of patients with cGVHD, with a Prescription Drug...