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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).
FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes drugs
July 12, 2021
Bayer announced today the FDA has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death.
President Biden’s Executive Order to Support Biosimilar Drugs Will Provide Lower Cost Options for Patients firstwordpharma
July 12, 2021
The Biosimilars Forum applauds President Biden's directions to the U.S. Department of Health and Human Services "to increase support for generic and biosimilar drugs, which provide low-cost options for patients" .
Pfizer, U.S. health officials to discuss COVID boosters on Monday firstwordpharma
July 12, 2021
Pfizer said Sunday that it will meet with representatives of the FDA as soon as Monday to discuss the need for a booster dose of its COVID-19 vaccine as it prepares to seek authorization, as reported in Investing.com.
FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes fda.gov
July 12, 2021
FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated.

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