January 20, 2021 by Chain Drug Review
Dr. Janet Woodcock, FDA
Leading Headlines, Pharmacy

WASHINGTON— Dr. Janet Woodcock, who has led the Food and Drug Administration’s drug review efforts for years, has been tapped to lead the agency on an interim basis after current Commissioner Stephen Hahn leaves office today. President-elect Joe Biden has yet to nominate an FDA commissioner. Dr. Hahn has designated Dr. Woodcock as interim commissioner
December 18, 2020 by Chain Drug Review
Dr. Stephen Hahn, FDA, Moderna Vaccine
Leading Headlines, Pharmacy

WASHINGTON — The Food and Drug Administration formally authorized a second vaccine for emergency use from Moderna. The biotech upstart won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be 94% effective at preventing the disease. “With the availability of two vaccines now for the prevention of
December 17, 2020 by Chain Drug Review
COVID-19, FDA, Moderna Vaccine
Leading Headlines, Pharmacy

WASHINGTON — A panel of outside advisers to the U.S. Food and Drug Administration on Thursday endorsed emergency use of Moderna’s coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation. Members of the Vaccines and Related Biological Products Advisory Committee voted 20-0 with one abstention in favor of
December 15, 2020 by Chain Drug Review
Dr. Stephen Hahn, Ellume COVID-19 Home Test, FDA
Leading Headlines, Pharmacy

WASHINGTON — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (O-T-C) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments
December 10, 2020 by Chain Drug Review
COVID-19 vaccine, Dr. Stephen Hahn, FDA, Pfizer
Leading Headlines, Pharmacy

WASHINGTON — Commissioner Stephen Hahn said ahead of today’s meeting of the Food and Drug Administration’s vaccine advisory panel is “an important day for all of America.” Pfizer’s COVID-19 vaccine faces one last hurdle as it races to become the first shot greenlighted in the U.S. — a panel of experts who will carefully scrutinize
December 8, 2020 by Chain Drug Review
COVID-19, FDA
Leading Headlines, Pharmacy

WASHINGTON — The coronavirus vaccine from Pfizer and BioNTech is said to offer strong protection against COVID-19 within about 10 days of the first dose, according to information published on Tuesday by the Food and Drug Administration ahead of a meeting of its vaccine advisory group. The finding is one of several significant new results
November 20, 2020 by Chain Drug Review
BioNTech SE, COVID-19 vaccine, Dr. Albert Bourla, FDA, Pfizer
Leading Headlines, Pharmacy

NEW YORK — Pfizer and BioNTech SE announced they will submit a request Friday to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of
November 18, 2020 by Chain Drug Review
FDA, FDA Commissioner Dr. Stephen Hahn, Lucira Health’s rapid coronavirus test
Pharmacy, Supplier News

WASHINGTON — The FDA has issued an Emergency Use Authorization (EUA) for Lucira Health’s rapid coronavirus test, the first one authorized for self-testing at home and priced at an affordable $50. The molecular single-use test, the All-In-One Test Kit, detects SARS-CoV-2 using self-collected nasal swab samples. Under the EUA, it may be used in the
August 27, 2020 by Chain Drug Review
Abbott, BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection, COVID-19, FDA
Leading Headlines, Pharmacy, Supplier News

ABBOTT PARK, Ill. — Abbott announced on Wednesday that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results
August 24, 2020 by Chain Drug Review
Dr. David Gortler, FDA
Leading Headlines, Pharmacy

ARLINGTON HEIGHTS, Ill. – The White House has brought on a new Executive Schedule Appointee David Gortler PharmD, FCCP to the FDA’s senior leadership team. Dr. David Gortler will serve as Senior Advisor to Commissioner and FDA chief, Steven Hahn MD as a drug safety expert and FDA policy. To the best of our knowledge,
July 14, 2020 by Chain Drug Review
Alcon, Dr. Michael Cooper, FDA, Pataday Once Daily Relief Extra Strength, Sergio Duplan
Leading Headlines, Supplier News

GENEVA – Alcon announced Tuesday that Pataday Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%), formerly prescribed as Pazeo, has been approved by the Food and Drug Administration (FDA) for sale over-the-counter (O-T-C) in the United States. Pataday Once Daily Relief Extra Strength is the first and only once daily eye allergy itch
July 9, 2020 by Chain Drug Review
current cannabidiol (CBD) marketplace, FDA, The Consumer Healthcare Products Association (CHPA)
Leading Headlines, Supplier News

WASHINGTON — The Consumer Healthcare Products Association (CHPA) released the following statement in response to the U.S. Food and Drug Administration (FDA) report to Congress on the current cannabidiol (CBD) marketplace: “While CHPA welcomes additional input from FDA regarding CBD, we’re concerned that the report conclusion further delays any action to better regulate CBD-containing products.
June 26, 2020 by Chain Drug Review
Dravet syndrome, FDA, Fintepla (fenfluramine)
Pharmacy

SILVER SPRING, Md. — The U.S. Food and Drug Administration approved on Friday Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite
May 18, 2020 by Chain Drug Review
BioSig Technologies, FDA, merimepodib oral solution, Nick Spring, ViralClear Pharmaceuticals
Pharmacy, Supplier News

WESTPORT, Conn.— BioSig Technologies announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or