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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).
FDA Approves Accelerated Dosing in Non-Hodgkin's Lymphoma/Leukemia Clinical Trial americanpharmaceuticalreview
July 14, 2021
AVM Biotechnology, a clinical-stage company, announced FDA permission to modify its ongoing non-Hodgkin's lymphoma/leukemia clinical study.
US FDA adds new warning on J&J COVID-19 vaccine for Guillain-Barre´ syndrome expresspharma
July 14, 2021
It said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.
FDA Head Asks for Investigation Into Alzheimer Disease Drug Approval drugs
July 13, 2021
The controversial U.S. Food and Drug Administration approval of the Alzheimer disease drug Aduhelm should be investigated by the Office of Inspector General (OIG), FDA Acting Commissioner Janet Woodcock, M.D., has said.
FDA Adds Guillain-Barré Warning to J&J COVID-19 Vaccine drugs
July 13, 2021
The U.S. Food and Drug Administration issued a new warning for the Johnson & Johnson COVID-19 vaccine that says the shot has been tied to Guillain-Barré syndrome.
FDA Approves Expanded Sterilization and Disinfectant Methods for the LUMINELLE® DTx System prnewswire
July 13, 2021
UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the Company's expanded reprocessing procedures for use with the LUMINELLE DTx System.
Valneva’s chikungunya virus vaccine granted breakthrough designation pharmatimes
July 12, 2021
French speciality vaccine company Valneva has announced that its single-shot chikungunya vaccine candidate has received a breakthrough therapy designation from the US Food and Drug Administration (FDA).

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