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The Latest Breaking News from FDA

FDA Approves Regeneron and Sanofi's Dupixent (dupilumab) For Eosinophilic Esophagitis (EoE) Ahead of Schedule

The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals, Inc.

Benzinga

New FDA 510(k) Clearance Expands Anika's Sports Medicine Soft Tissue Portfolio

Anika Therapeutics Inc (NASDAQ:ANIK) has received FDA 510(k) clearance for the X-Twist Knotless Fixation System, a platform of suture anchors designed to be mechanically robust, easy to use, and support healing for critical repairs such as rotator cuff repair. According to SmartTRAK, nearly 670,000 rotator cuff procedures were performed in 2021, mainly in…

Benzinga

AbbVie Submits FDA Application For Continuous, 24-Hour Infusion Therapy For Parkinson's

AbbVie Inc (NYSE:ABBV) submitted its FDA marketing application for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy. AbbVie’s theory here revolves around using a continuous, 24-hour infusion of its therapy. The levodopa and carbidopa prodrugs are delivered in small doses…

Benzinga

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CHMP Backs Approval of Lilly/Incyte's Olumiant For Patchy Hair Loss

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Eli Lilly And Co (NYSE:LLY) and Incyte Corporation's (NASDAQ:INCY) Olumiant (baricitinib) for severe alopecia areata (AA). If approved, Olumiant would be the first centrally-authorized oral treatment and first JAK inhibitor for severe AA in the European Union. …

Benzinga

Mid-Afternoon Market Update: Dow Dips Over 500 Points; Ross Stores Shares Slide

U.S. stocks extended losses toward the end of trading, with the Dow Jones dropping more than 500 points on Friday.

Benzinga

The Trials And Tribulations Of Psychedelic Research

This article by Natasha Sumner was originally published on Microdose and appears here with permission.

Benzinga

Is Trump to blame for the baby formula shortage?

Reexamining a trade deal with bipartisan support

The Independent UK

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Mid-Day Market Update: Dow Tumbles 200 Points; TherapeuticsMD Shares Jump

U.S. stocks traded lower midway through trading, with the Dow Jones dropping around 200 points on Friday.

Benzinga

38 Stocks Moving In Friday's Mid-Day Session

Gainers Leju Holdings Limited (NYSE: LEJU) surged 27.8% to $4.0413.

Benzinga

LPCN: OLE Results

By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT

Benzinga

Cannabis Regulatory Update: FDA On CBD Reg Stalling, NY Issues 58 Cannabis Grow Licenses, LA's State Worker Protections

FDA Chief Recognizes Slow Progress On CBD Regulations Dr. Robert M. Califf confirmed on Thursday at a congressional panel that the FDA has made little progress on the regulatory framework around CBD products over the years since Trump signed the Farm Bill in late 2018.

Benzinga

Why TherapeuticsMD Shares Are Trading Higher Today

TherapeuticsMD Inc (NASDAQ:TXMD) shares are trading higher after FDA approved the supplemental application, including minor revisions to Annovera's in vitro release testing specification that allowed for normal manufacturing variability. The FDA approved Annovera in August 2018 as the only long-lasting, reversible, procedure-free birth control. With the approval of the supplemental application, the company believes…

Benzinga

Mid-Morning Market Update: Markets Open Higher; Deere Tops Q2 Views

U.S. stocks traded higher this morning. Following the market opening Friday, the Dow traded up 0.20% to 31,316.89 while the NASDAQ rose 0.35% to 11,428.90. The S&P also rose, gaining, 0.34% to 3,914.24.

Benzinga

Baby formula shortage shows risk of US industry concentration

Formula isn’t just for babies. April Crohare desperately needs it for her 14-year-old son, Charlie. Due to medical complications from a rare brain disorder called lissencephaly, his only source of nutrition comes from infant formula through a feeding tube.

Tribune News Service

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Benzinga

The Daily Biotech Pulse: CDC Recommends COVID-19 Boosters For Kids 5-11, Foghorn's Blood Cancer Trial On Clinical Hold, Bayer Intends To Bow Out From CAR-T Therapy Pact With Atara

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

Benzinga

CDC Recommends Pfizer/BioNTech COVID-19 Booster Shots For Kids Aged 5-11 Years

The Centers for Disease Control and Prevention recommended that children ages 5 to 11 receive the newly authorized COVID-19 booster shot from Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX). Following the recommendation, many of the nation's doctors, pharmacies, and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children…

WEKU

Telehealth abortion demand is soaring. But access may come down to where you live

Recent rule changes made it easier for patients to get abortion pills through the mail, using telehealth services. Now there is growing demand for these services – and new legal battles brewing.

Benzinga

FDA Places Clinical Hold On Foghorn Therapeutics' Early-Stage Blood Cancer Trial

The FDA has instituted a clinical hold on Foghorn Therapeutics Inc's (NASDAQ:FHTX) Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The FDA initiated the partial clinical hold following the report of a recent death that occurred in a subject with potential differentiation syndrome. Differentiation…

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The Guardian - US

Baby formula crisis: Abbott enriched shareholders as factory needed repairs, records show

Economists condemn ‘rot’ in system after manufacturer issued billions in stock buybacks despite problems at Michigan factory

Benzinga

71 Biggest Movers From Yesterday

Gainers NeuroMetrix, Inc. (NASDAQ: NURO) shares jumped 76.3% to close at $5.50 on Thursday after the company announced the FDA has granted De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia.

The Independent UK

Liberals are blaming Donald Trump for the baby formula shortage, but is that accurate?

Reexamining a trade deal with bipartisan support

Benzinga

Markets Finish Lower Following Wednesday's Intense Sell-Off

U.S. indices finished Thursday's trading session lower. Worse-than-expected retail earnings and anticipation of further Federal Reserve policy tightening in 2022 have continued to weigh on stocks across sectors.

Tribune News Service

Abbott baby formula factory could reopen by next week, FDA head says

An Abbott baby formula plant in Michigan that’s been shut down since February could be up and running as early as next week, the head of the Food and Drug Administration told lawmakers Thursday.

Al Jazeera

US baby formula crisis: What you need to know

Why is there an infant formula shortage in the US? Who is to blame? And when will parents see relief?

WEKU

FDA head says baby formula factory could reopen in the next week or two

But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.

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