OB_1170x120_9-14-20

FDA

FDA clears Moderna vaccine for COVID-19

FDA clears Moderna vaccine for COVID-19

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

Panel greenlights Moderna vaccine, paving way for FDA authorization

Panel greenlights Moderna vaccine, paving way for FDA authorization

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

FDA authorizes antigen test as first O-T-C fully at-home diagnostic test for COVID-19

FDA authorizes antigen test as first O-T-C fully at-home diagnostic test for COVID-19

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

Today’s FDA panel meeting could lead to Pfizer getting vaccine emergency use okay

Today’s FDA panel meeting could lead to Pfizer getting vaccine emergency use okay

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

Pfizer seeking emergency use of its COVID-19 vaccine

Pfizer seeking emergency use of its COVID-19 vaccine

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

Lucira Health’s Rapid Home COVID-19 test gets EUA

Lucira Health’s Rapid Home COVID-19 test gets EUA

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

Abbott’s 15-minute, $5 COVID-19 test gets FDA authorization

Abbott’s 15-minute, $5 COVID-19 test gets FDA authorization

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

Alcon announces FDA approval of the O-T-C switch of Pataday Once Daily Relief Extra Strength

Alcon announces FDA approval of the O-T-C switch of Pataday Once Daily Relief Extra Strength

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

CHPA: FDA report to congress on CBD underscores need for regulation

CHPA: FDA report to congress on CBD underscores need for regulation

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.

FDA approves new therapy for Dravet syndrome

FDA approves new therapy for Dravet syndrome

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

FDA completes review investigational new drug application from BioSig

FDA completes review investigational new drug application from BioSig

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

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