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The Latest Breaking News from FDA

Baby milk brand used to wean Prince Louis in 'advanced discussions' to help formula shortage in USA

Kendal Nutricare said it expects to ship 100 trucks to the USA over the next six months

Birmingham Post

FDA chief to detail delays inspecting baby formula plant

The head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage

The Independent UK

SVB Sees Strategic Value In This Stock As M&A Target In Autoimmune Space

SVB Securities initiated coverage on Argenx SE (NASDAQ:ARGX) with an Outperform rating and a $404 price target. Argenx's Vyvgart (efgartigimod) is a neonatal Fc-Receptor (FcRn) antagonist that selectively reduces IgG levels and has the potential to address numerous IgG-mediated autoimmune diseases. According to the analyst, Argenx has demonstrated strong early launch execution for Vyvgart…

Benzinga

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

Alnylam's Lumasiran Shows Clinical Benefit In Rare Kidney Disease

Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) announced new results from the six-month primary analysis of the ILLUMINATE-C Phase 3 open-label study of lumasiran for primary hyperoxaluria type 1 (PH1). PH1 is a rare disorder that mainly affects the kidneys. It results from the buildup of a substance called oxalate, typically filtered through the kidneys and…

Benzinga

50 Stocks Moving In Tuesday's Mid-Day Session

Gainers CynergisTek, Inc. (NYSE: CTEK) jumped 100% to $1.18 after the company entered into a definitive agreement to be acquired by Clearwater Compliance for roughly $17.7 million.

Benzinga

Cannabis Strain Labels Are Misleading, Research Suggests: Authors Call For Labeling Similar To FDA For Food

Do you know what kind of weed you're smoking? Have you ever wondered how useful labels on cannabis products are, or not?

Benzinga

US safety, savings rules set stage for baby formula shortage

A massive recall is getting most of the blame for the U.S. baby formula shortage, but experts say the products have long been vulnerable to this type of crisis

The Independent UK

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RVPH: First Quarter Results

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

Benzinga

Ocugen Diversifies Its Pipeline With New Cell Therapy Platform

Ocugen Inc (NASDAQ:OCGN) says it is diversifying its pipeline by introducing a Phase 3 cell therapy platform technology called NeoCart (autologous chondrocyte-derived neocartilage). Recently, the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to NeoCart to repair full-thickness lesions of the knee cartilage in adults. NeoCart is a three-dimensional tissue-engineered disc of…

Benzinga

FDA Lifts Partial Hold On Alpine Immune's Davoceticept Combo Trial In Advanced Cancer

The FDA has removed the partial clinical hold placed on Alpine Immune Sciences Inc's (NASDAQ:ALPN) NEON-2 trial of davoceticept (ALPN-202) in advanced malignancies. Davoceticept is a first-in-class conditional CD28 costimulator and a dual checkpoint inhibitor. The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial. The trial is evaluating davoceticept…

Benzinga

Why SpringWorks Shares Are Soaring Today Premarket

SpringWorks Therapeutics Inc (NASDAQ: SWTX) has announced positive topline results from the DeFi Phase 3 trial evaluating nirogacestat in adult patients with progressing desmoid tumors.

Benzinga

The Daily Biotech Pulse: INmune Bio's Planned Alzheimer's Trial On FDA Hold, Caladrius Stops Enrollment In Heart Disease Study, BiomX Restructures

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

Benzinga

58 Biggest Movers From Yesterday

Gainers Catalyst Biosciences, Inc. (NASDAQ: CBIO) gained 234.2% to close at $1.27 after the company announced it sold its complement portfolio for $60 million.

Benzinga

With Roe v. Wade at risk, Planned Parenthood of Illinois makes abortion pills available by mail for state residents

CHICAGO — With the U.S. Supreme Court poised to overturn Roe v. Wade, Planned Parenthood of Illinois said Monday it has begun offering abortion pills by mail for state residents who qualify.

Chicago Tribune

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news in one place.

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Benzinga

Jif Peanut Butter Recall In US And Canada Due To Salmonella: What You Need To Know

The U.S.

Salon

Jif peanut butter is being recalled

The recall includes nearly 50 products

Benzinga

The Analyst Says 'Impressive Phase 3 Data Highlight Best-In-Class Opportunity' For Concert Pharma

Concert Pharmaceuticals Inc (NASDAQ:CNCE) has released highly positive Phase 3 data for their alopecia areata drug CTP-543 from the THRIVE-AA1 trial. Mizuho says that the efficacy supports its view that CTP-543 potentially has best-in-class efficacy amongst the three main oral JAK inhibitors in late-stage development for alopecia areata (CTP-543, Eli Lilly And Co's (NYSE: LLY)…

Benzinga

Read Why Did HC Wainwright Cut Price Target On Atara Biotherapeutics

Late last week, Atara Biotherapeutics Inc (NASDAQ:ATRA) announced that Bayer AG (OTC:BAYRY) intends to terminate the exclusive worldwide licensing agreement for Atara's mesothelin-targeted allogeneic and autologous CAR-T assets, ATA3271 and ATA2271. The enrollment was paused in the Phase 1 trial of ATA2271 for mesothelioma after a patient death. The move followed a strategic review and asset-level prioritization.…

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The Independent UK

What's next for COVID-19 vaccines for youngest US children

Parents hoping to get their youngest children vaccinated against COVID-19 have some encouraging news

Benzinga

What's Going On With ImmunoGen Shares Today?

ImmunoGen, Inc. (NASDAQ: IMGN) shares are trading flat at $3.57 after the company's Biologics License Application to treat ovarian cancer was accepted by the FDA with priority review.

Benzinga

Biohaven's Neurological Disease Candidate Flunks In Late-Stage Study

Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) has announced topline Phase 3 results of troriluzole in patients with spinocerebellar ataxia (SCA). The primary endpoint measured the change in the severity of symptoms among patients from the baseline to week 48 of treatment. It did not reach statistical significance in the overall SCA population as…

Benzinga

Seagen Posts Encouraging Data From Tucatinib Combo Trial In Colorectal Cancer

Seagen Inc (NASDAQ:SGEN) announced topline results from phase 2 MOUNTAINEER trial investigating Tukysa (tucatinib) in combination with trastuzumab in previously treated HER2-positive metastatic colorectal cancer (mCRC) patients. Trastuzumab is sold under the name Herceptin by Genentech, a unit of Roche Holdings AG (OTC:RHHBY). Data from this trial will form the basis of a planned supplemental…

Benzinga

Innoviva Acquires AstraZeneca-Spin Off At $2.20/Share

Innoviva Inc (NASDAQ:INVA) has agreed to acquire Entasis Therapeutics Holdings Inc (NASDAQ:ETTX) at $2.20 per share in cash. Innoviva currently owns approximately 60% of the outstanding shares of Entasis common stock. The acquisition consideration values Entasis' equity at $113 million on a fully diluted basis. "This acquisition will build upon our overall strategy to acquire differentiated,…

Benzinga

Why Nymox Pharma Shares Sinking to 52-Week Low?

Nymox Pharmaceutical Corporation (NASDAQ:NYMX) has received a Refusal to File (RTF) letter from FDA regarding its marketing application for Fexapotide Triflutate. Nymox's position is that clarifications remain to be resolved at a follow-up meeting and that some significant inconsistencies were involved. In March, the company submitted a Fexapotide Triflutate application for benign prostatic…

Benzinga

FDA Removes Clinical Hold On Ocugen's COVID Vaccine Trial

The FDA has lifted the clinical hold on Ocugen Inc's (NASDAQ:OCGN) Phase 2/3 trial, OCU-002, for Covaxin (BBV152), a whole virus inactivated COVID-19 vaccine candidate. In April, the agency paused the trials of the shot, Covaxin, after an inspection of a Bharat Biotech facility by the World Health Organization (WHO) revealed deficiencies…

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