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Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease drugs
July 20, 2021
FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in NDD adult patients.
Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film drugs
July 20, 2021
Aquestive Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters.
FDA Approves Fexinidazole as the First All-Oral Treatment for Sleeping Sickness drugs
July 20, 2021
The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness in patients 6 years of age and older and weighing at least 20 kg.
Merck gets US FDA nod of adult pneumococcal 15-valent conjugate vaccine expresspharma
July 19, 2021
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.
FDA Vote on Roxadustat in Anemia of Chronic Kidney Disease americanpharmaceuticalreview
July 19, 2021
The FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult ...
FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD) drugs
July 19, 2021
Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients 12 years and older with cGVHD.
FDA to Prioritize Full Approval for Pfizer COVID-19 Vaccine drugs
July 19, 2021
Pfizer Inc. announced on Friday that the U.S. Food and Drug Administration has granted priority review to its COVID-19 vaccine, positioning the vaccine for full approval by January.
Two Major Health Systems Will Not Administer Controversial Aduhelm drugs
July 16, 2021
Two major U.S. health systems say they will not administer Aduhelm, the controversial new drug for treating Alzheimer disease.
U.S. FDA Grants Regular Approval and Expands Indication for Padcev (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer drugs
July 16, 2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted Padcev (enfortumab vedotin-ejfv) regular approval in the U.S.
FDA Grants Breakthrough Therapy Designation for Stargardt Disease Treatment americanpharmaceuticalreview
July 15, 2021
Alkeus Pharmaceuticals, Inc., a private, late-stage biopharmaceutical company, announced that the U.S. FDA granted Breakthrough Therapy Designation to ALK-001 for the treatment of Stargardt Disease.

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