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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.
Tezepelumab Granted Priority Review By U.S. FDA drugs
July 15, 2021
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma.
NexImmune Strengthens Management Team with Key Appointments firstwordpharma
July 15, 2021
NexImmune, Inc. (Nasdaq: NEXI) today announced that Jack A. Ragheb, MD, PhD, has been appointed to the newly created position of Senior Vice President, Translational Science, bringing more than 30 years of experience in translational and clinical research
Direct Biologics Announces FDA Acceptance of IND Application for a Phase I/II Clinical Trial Studying ExoFlo for Acute Respiratory Distress Syndrome prnewswire
July 15, 2021
Direct Biologics announced today that the U.S Food and Drug Administrationhas approved its Investigational New Drug (IND) application to conduct a Phase I/II clinical trial using ExoFlo™ in the treatment of Acute Respiratory Distress Syndrome (ARDS).

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