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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 (Tagrisso), a medicine made by AstraZeneca, is a licensed treatment for patients with mid and later ...

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 treatment is limited to surgery and adjuvant chemotherapy. 2 Unprecedented clinical trial data show that o...

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 we believe that belumosudil, if approved, will serve a critical, unmet need for patients with cGVH...

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 that belumosudil, if approved, will serve a critical, unmet need for patients with cGVHD," said Harla...

(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 User Fee Act (PDUFA) goal date of August 30, 2021. "The results from our first clinical study in cG...