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The Latest Breaking News from FDA

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

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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:

Benzinga

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

Salon

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…

The Conversation

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)…

Benzinga

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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.

Los Angeles Times

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’

The Independent UK

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).

Benzinga

3 Low-Beta Stocks to Buy to Combat a Jittery Market

The Fed’s aggressive interest rate increases to tame multi-decade high inflation, and an anticipated economic slowdown, have exacerbated market volatility of late. To protect against the market uncertainties, we think investors should consider investing in low-beta stocks Merck (MRK), Gilead Sciences (GILD), and AmerisourceBergen (ABC). Let’s discuss why.

StockNews.com

FDA Allows Import Of 2M Baby Formula Cans Amid Supply Shortage: Reuters

The FDA is easing regulations to allow infant formula imports from Britain, bringing around 2 million cans onto empty shelves by June to ease a nationwide shortage, Reuters reported. The FDA said it was "exercising enforcement discretion" to allow Britain-based Kendal Nutricare to import certain infant formula products under the Kendamil…

Benzinga

Citius Pharma To Spinoff Late-Stage Oncology Asset Into New Publicly Traded Firm

Citius Pharmaceuticals Inc (NASDAQ:CTXR) plans to form a new company (NewCo) focused on developing and commercializing I/ONTAK. A Phase 3 trial was completed in December 2021, and a biologics license application (BLA) is being planned for submission in the second half of 2022. The Company's other pipeline assets, including Mino-Lok, would remain at…

Benzinga

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Benzinga

Elevation Oncology Shares Gain On FDA Fast Track Designation For Seribantumab In Tumor-Agnostic Settings

Elevation Oncology, Inc. (NASDAQ: ELEV) received Fast Track designation from the Food and Drug Administration (FDA) for Seribantumab in tumor-agnostic settings for the treatment of advanced solid tumors that harbor NRG1 gene fusions.

Tribune News Service

Millions of imported baby formula cans are heading to the US, FDA says

Millions more cans of baby formula will be available in the U.S. in the coming months, the nation’s Food and Drug Administration said, detailing steps it’s taken to alleviate a shortage that has left families scrambling to figure out how to feed their babies.

Benzinga

The Daily Biotech Pulse: Third FDA Rejection For Verrica's Skin Disease Drug, Assembly Bio Terminates Hepatitis B Virus Pact, Consistency Data For Valneva's Chikungunya Vaccine

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

Benzinga

Why Verrica Pharma Shares Are Plunging Today

The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc's (NASDAQ:VRCA) marketing application for VP-102 for molluscum contagiosum. The only deficiency listed in the CRL was related to the deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services LLC, the contract manufacturing organization that manufactures Verrica's bulk solution drug product. …

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The Guardian - UK

UK baby milk maker to fly formula to US to help ease shortages

Lake District-based Kendamil steps in after largest producer in US had nationwide recall

Benzinga

71 Biggest Movers From Yesterday

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

Birmingham Post

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

The Independent UK

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

Benzinga

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

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.

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