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
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 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
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,
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
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.
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
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
WASHINGTON — On Friday, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the
DEERFIELD BEACH, Fla. — The National Institutes of Health (NIH) released a statement this week warning against the use of hydroxychloroquine (HCQ) in combination with azithromycin. This conclusion mirrors Agilum Healthcare Intelligence’s real-world evidence published two weeks earlier on April 7th. Agilum was also pleased that the U.S. Food and Drug Administration (FDA) issued a
WASHINGTON — The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test
WASHINGTON — The U.S. dietary supplement industry commends the Food and Drug Administration (FDA) for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2. In February, the industry issued strong warning to companies and consumers to avoid
WASHINGTON — The U.S. Food and Drug Administration issued the first Emergency Use Authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out
WASHINGTON — The U.S. Food and Drug Administration Wednesday has issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. Challenges may arise, for example,