Myelosuppression Archives

Spectrum Pharma’s Rolontis Denied in Neutropenia

Biologics License Application (BLA), Biologics License Application (BLA), Clinical Trials, Complete Response Letter, FDA, Myelosuppression, Neutropenia, R&D

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Henderson, Nev.-based Spectrum Pharmaceuticals.

August 9, 2021/by Andrew Humphreys

Sierra Signs Exclusive Deal with AstraZeneca for Potent BRD4 BET Inhibitor

AstraZeneca, BET inhibitors, Biopharmaceutical, Business, Clinical Trials, Deals, JAK1 Inhibitors, Myelofibrosis, Myelosuppression, R&D

Sierra Oncology, a late-stage biopharmaceutical firm specializing in treatments for rare cancers, signed an exclusive deal to use AstraZeneca’s product to develop a potential new drug for myelofibrosis.

August 6, 2021/by Andrew Humphreys

FDA Approves G1 Therapeutics’ Cosela to Prevent Chemo Damage in Lung Cancer

Approvals, Bone Marrow, Chemotherapy, Chemotherapy-induced myelosuppression, Clinical Data, Clinical Trials, Extensive-Stage Small Cell Lung Cancer, FDA, FDA/Regulatory, Immune System, Myelosuppression, R&D, Therapeutics

The U.S. Food and Drug Administration approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy.

February 15, 2021/by Andrew Humphreys

FDA Action Alert: Merck, Aurinia and Amgen

Amgen, Business, Calcineurin Inhibitors (CNI), Chronic Heart Failure, Clinical Trials, Collaborations, Deals, FDA, FDA, Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS), Lupus nephritis, Merck, Myelosuppression, New Drug Application (NDA), PDUFA, Priority Review, R&D, Systemic Lupus Erythematosus (SLE)

After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up, according to BioSpace.

January 18, 2021/by Andrew Humphreys