The Latest Breaking News from FDA

Like Pfizer, Moderna Seeks FDA Approval For Fourth COVID-19 Shot Or Second Booster Dose

Moderna Inc (NASDAQ: MRNA) has asked the FDA to authorize a 

Benzinga · Mar 18, 2022

Moderna Seeks US Approval of Second Covid Booster

Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults. The request to the US Food and Drug Administration (FDA) would "allow for a fourth dose of our #COVID19 vaccine in adults 18…

Asharq Al-Awsat · Mar 18, 2022

Carcinogenic chemical benzene found in hundreds of US personal care products

Independent lab found the chemical in more than a quarter of items it tested – sometimes at levels considered ‘life threatening’

The Guardian - US · Mar 18, 2022

Why Are TC Biopharm Shares Trading Higher Today

The FDA has granted Orphan Drug designation to TC Biopharm Ltd's (NASDAQ:TCBP) lead product OmnImmune for use in Acute Myeloid Leukemia.  After reviewing the Phase 1b/2a trial results in relapsed/refractory AML patients, the FDA approved the Company's application for Orphan Drug Status. "We look forward to the advancement of OmnImmune® in the Phase 2b/3…

Benzinga · Mar 17, 2022

Aquestive's AQST-109 Receives Fast Track Tag For Allergic Reactions

The FDA has granted Fast Track Designation to Aquestive Therapeutics Inc's (NASDAQ: AQST) AQST-109 for allergic reactions. AQST-109 is an orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis.

Benzinga · Mar 17, 2022

FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease

InflaRx N.V. (NASDAQ: IFRX) has 

Benzinga · Mar 17, 2022

As abortion pills take off, some states move to curb them

In June, the U.S. Supreme Court is expected to weaken or topple its nearly 50-year-old abortion rights decision, Roe v. Wade, giving states wide latitude to restrict the procedure.

Tribune News Service · Mar 17, 2022

FDA Clears AbbVie's Rinvoq For Moderate To Severe Active Ulcerative Colitis

The FDA approved AbbVie Inc's (NYSE:ABBV) Rinvoq (upadacitinib) for adults patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers.  This FDA approval is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from…

Benzinga · Mar 17, 2022

80 Biggest Movers From Yesterday

Gainers Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) shares gained 86.7% to close at $0.5150 on Wednesday after the company announced FDA clearance of its IND for SON-1010 for the treatment of advanced solid tumors.

Benzinga · Mar 17, 2022

Second COVID-19 booster shot does little to stop omicron, study finds

Israeli health care workers who were boosted with a fourth shot of COVID-19 vaccine at the height of the omicron wave were only marginally more protected against reinfection than their peers who had received three jabs of vaccine, researchers reported Wednesday.

Los Angeles Times · Mar 17, 2022