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The Latest Breaking News from FDA

NOT REAL NEWS: A look at what didn't happen this week

Social media users shared a range of false claims this week

The Independent UK

Revive Therapeutics: Positive Comments From The FDA Regarding Primary Endpoint Change

The outlook for Revive Therapeutics Ltd. (OTC: RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19 got a little brighter on Thursday.

Benzinga

The FDA Completely Botched Its Response to the Baby Formula Shortage

Plus: Resurrecting an extinct tiger, reviewing the police response to the Uvalde shooting, and more...

Reason

From analysis to the latest developments in health,
read the most diverse news in one place.

FDA Battles Over CBD Hype Yet Again, This Time Warns Businesses Selling Illegal CBD For Food-Producing Animals

The Food and Drug Administration (FDA) sent letters to four CBD companies warning them against selling unauthorized CBD products for use in food-producing animals. Companies being warned are Haniel Concepts (doing business as Free State Oils), Hope Botanicals, Plantacea LLC (doing business as Kahm CBD

Benzinga

Abortion Pills - The Next Battleground In USA

The United States Supreme Court has not yet released its judgment, limiting abortion rights significantly.

Benzinga

88 Biggest Movers From Yesterday

Gainers Creatd, Inc. (NASDAQ: CRTD) shares jumped 58.5% to close at $1.28 on Thursday. Creatd’s board approved a rights offering of up to $40 million for 20 million shares at $2 per unit.

Benzinga

Mid-Afternoon Market Update: Dow Surges 575 Points; Apyx Medical Shares Spike Higher

U.S. stocks traded higher toward the end of trading, with the Dow Jones gaining 575 points on Thursday.

Benzinga

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High Hopes For Alcohol Use Disorder Treatment: Clearmind's Successful Pre-IND Meeting With The FDA

The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage.

Benzinga

Apyx Medical Stock Gains Following FDA Clearance of Renuvion Dermal Handpiece for Wrinkle Reduction

The U.S. Food and Drug Administration (FDA) announced 510(k) clearance (pre-market notification) of Apyx Medical’s (NASDAQ: APYX) Renuvion Dermal Handpiece for specific dermal resurfacing procedures.

Benzinga

Why Apyx Medical Shares Are Trading Higher Today?

Apyx Medical Corporation (NASDAQ:APYX) has FDA received 510(k) clearance for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for dermatological procedures to treat moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III. The company expects…

Benzinga

Mid-Day Market Update: Crude Oil Jumps Over 3%; NRx Pharmaceuticals Shares Tumble

U.S. stocks traded higher midway through trading, with the Dow Jones gaining around 1.5% on Thursday.

Benzinga

The Jif peanut butter recall is pulling a cascade of other products from store shelves

Many other companies use the peanut butter — the cause of a salmonella outbreak — and now they have recalls of their own. The FDA says the products made it to at least 10 other countries.

WEKU

61 Stocks Moving In Thursday's Mid-Day Session

Benzinga

Lawmakers Seek Answers From FDA, Abbott On Nationwide Baby Formula Shortage

FDA officials appeared before a congressional panel to answer questions about the crisis after Abbott Laboratories (NYSE: ABT) recalled some baby formula products and closed its manufacturing plant in Sturgis, Michigan.

Benzinga

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news in one place.

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Benzinga

Mid-Morning Market Update: Markets Open Higher; US Economy Contracts 1.5% In Q1

U.S. stocks traded higher this morning, with the Nasdaq Composite gaining around 200 points on Thursday.

Benzinga

Pharma Stock Shoots Up As FDA Accepts NDA For Neuromuscular Disorder Drug Under Priority Review

Reata Pharmaceuticals (NASDAQ: RETA) announced that the U.S. Food and Drug Administration has accepted New Drug Application (NDA) for its lead drug candidate omaveloxolone for the treatment of patients with Friedreich's ataxia.

Benzinga

Pfizer's Combo Therapy For Fatty Liver Disease Gets FDA Fast Track Status

The U.S. Food and Drug Administration has granted Fast Track designation to Pfizer’s (NYSE: PFE) Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).

Benzinga

The Daily Biotech Pulse: Setback For NRx Pharma's COVID Study, Fast Track Tag For Pfizer's NASH Combo Therapy, Reata's Ataxia Drug In FDA Review

Here's a roundup of top developments in the biotech space over the last 24 hours:

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news in one place.

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One news app.

Salon

Climate change brings mold to Corn Belt

Aflatoxin, a chemical produced by infectious mold, could be coming to the Corn Belt thanks to climate change

The Conversation

How important is the COVID-19 booster shot for 5-to-11-year-olds? 5 questions answered

COVID-19 case numbers are rising again in the U.S. – including among children. In mid-May 2022, the Food and Drug Administration authorized a booster shot of the COVID-19 vaccine for U.S. children ages 5 to 11, and the Centers for Disease Control and Prevention followed by recommending a booster shot…

Benzinga

Why NRX Pharmaceuticals Shares Are Trading Lower During Premarket On Thursday?

Based on the review of approximately 460 patients, Data Safety and Monitoring Board (DSMB) determined that the evaluation of NRx Pharmaceuticals Inc's (NASDAQ:NRXP) Zyesami (aviptadil) should cease due to futility. Aviptadil was the sole remaining investigational medicine in ACTIV-3b targeted at critical-ill COVID-19 patients. ACTIV-3b study evaluated Zyesami and Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir)…

Los Angeles Times

FDA acknowledges slow response, 'suboptimal' decisions leading up to infant formula shortage

WASHINGTON — Sluggish response and questionable decisions by the Food and Drug Administration exacerbated the nation's infant formula shortage, agency officials told lawmakers at a congressional hearing on Wednesday.

The Independent UK

FDA mail room ‘failure’ partly to blame for Abbott baby formula fiasco

FDA leadership didn’t ‘receive direct copies of the complaint due to an isolated failure in FDA’s mail room, likely due to COVID-19 staffing issues’

Benzinga

RBC Capital Slashes Verrica's Price Target After Third Rejection - What's Next?

Verrica Pharmaceuticals Inc (NASDAQ:VRCA) was slapped with a third FDA rejection for YCANTH (VP-102) as general contract manufacturing organization challenges continue to plague the approval. RBC Capital Markets has downgraded the stock to Sector Perform from Outperform and lowered the price target from $16 to $4. The analysts note that the issues fall outside of…

Benzinga

FDA Accepts Review Of Phathom Pharmaceuticals' NDA For Vonoprazan

The Food and Drug Administration (FDA) has accepted for review Phathom Pharmaceuticals’ (NASDAQ: PHAT) New Drug Application (NDA) of its lead drug candidate Vonoprazan for the healing of all grades of erosive esophagitis (EE).

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