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The Latest Breaking News from FDA

Aeglea BioTherapeutics Shares Plummet Following Refusal To File Letter From FDA

Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) announced the U.S. Food and Drug Administration (FDA) has refused to accept the company’s Biologics License Application (BLA) with a Refusal to File (RTF) letter.

Benzinga

PDS Biotechnology Gains On FDA Fast Track Designation For Lead Candidate

The U.S.

Benzinga

Cannabis Reg. Update: California's Safe Drug Consumption Sites, FDA's Advisory Panel Discusses CBD In Food & More

FDA Advisory Panel To Discuss CBD Use In Food & Dietary Supplements The Science Board of the FDA is scheduled to meet on Tuesday, June 14, to discuss “challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study.”

Benzinga

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FDA Accepts Myovant Sciences and Pfizer's Filing For Review In Uterine Fibroids

Myovant Sciences (NASDAQ: MYOV) and Pfizer (NASDAQ: PFE) received U.S.

Benzinga

Morning Brief: Top Financial Stories Dominating on Thursday, June 2

Reuters

Benzinga

Pfizer Seeks FDA Approval For Three Covid Vaccine Doses For Children Below Five

Partners Pfizer, Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) urged the FDA to authorize three vaccine doses for children below five, the Wall Street Journal reports. The companies previously asserted that three doses of the shot were 80% effective at preventing symptomatic Covid-19 with robust immune response in children between six months to five years. After mixed results…

Benzinga

62 Biggest Movers From Yesterday

Gainers Missfresh Limited (NASDAQ: MF) jumped 51.1% to close at $0.2450 on Wednesday.

Benzinga

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Proposed menthol ban highlights debate over ‘sin tax’ revenue - Roll Call

The FDA’s proposed ban on menthol cigarettes means states would see “sin tax” revenues fall, but vaping taxes are already filling the gap.

Roll Call

Pfizer submits COVID-19 shot for children under 5 for FDA authorization

WASHINGTON — Pfizer Inc. asked U.S. regulators to clear its COVID-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest.

Tribune News Service

Baby formula makers tell Biden they knew shortages would be dire

WASHINGTON — President Joe Biden defended his administration’s response to a national baby formula shortage, saying he acted as soon he became aware of the crisis in April — even as manufacturers told him Wednesday they saw it coming months earlier.

Tribune News Service

44 Stocks Moving In Wednesday's Mid-Day Session

Gainers

Benzinga

DEA Delays Medical Marijuana Clinical Trials Yet Illicit Market Continues To Thrive

As states legalize marijuana, some as long as 10 years ago, many are beginning to realize the public health and safety implications of a variety of new high-potency products

Benzinga

Midatech Pharma's Shares Shoot Higher On FDA Fast Track Designation For Malignant Brain Tumor Drug

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Midatech Pharma PLC's (NASDAQ: MTP) lead drug candidate MTX110 for the treatment of patients with recurrent glioblastoma (rGBM).

Benzinga

Pressure growing to remove PFAS from fast food wrappers

Environmental and health groups are pushing dozens of fast food companies, supermarkets chains and other retail outlets to remove PFAS from their packaging

The Independent UK

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Benzinga

Why Kymera Therapeutics Stock Is Gaining Wednesday

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Kymera Therapeutics (NASDAQ: KYMR) lead drug candidate KT-333 for the treatment of patients with Peripheral T-cell Lymphoma (PTCL).

Daily Mirror

Hepatitis outbreak in US linked to infected strawberries as experts issue warning

An outbreak of hepatitis A in the United States and Canada has potentially been linked to organic strawberries. What could this mean for the UK?

Reason

Are Pulse Oximeters "Intrinsically Biased Against People of Color?"

A Wall Street Journal article suggests that pulse oximeters mismeasure blood oxygen levels in American minority populations, but the article fails to ask some important questions.

Benzinga

Australia, New Zealand Express Support To Address USA Baby Food Crisis

Australia is in talks with the U.S. to supply baby food, Reuters reports.

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Benzinga

18 Stocks Moving in Wednesday's Pre-Market Session

Gainers Endo International plc (NASDAQ: ENDP) rose 46.1% to $0.7710 in pre-market trading after gaining over 12% on Tuesday.

Benzinga

77 Biggest Movers From Yesterday

Gainers TherapeuticsMD, Inc. (NASDAQ: TXMD) shares climbed 364% to close at $9.93 on Tuesday after the company announced it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners.

Bangkok Post

FDA launching website, app for registration of cannabis, hemp cultivation

The Food and Drug Administration is launching a phone app and a website for people to register their cultivation of cannabis and hemp plants, which are being removed from the category 5 narcotics list, FDA deputy secretary-general Withid Sariddeechaikool said on Wednesday.

Benzinga

Zero Cost, FDA CGMP Approved LSD For Qualified Researchers, Provided By Ceruvia Lifesciences

Ceruvia Lifesciences, a biopharmaceutical company, announced that it has produced the world's first LSD that meets stringent "Current Good Manufacturing Practices" (CGMP) standards required by the FDA for new drug approvals and is offering to supply it at no cost to qualified researchers.

Benzinga

Major Depressive Disorder Could Soon Have Treatment Option Via Cybin's Psilocybin Analog

Cybin Inc. (CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics," has submitted an Investigational New Drug (or “IND”) application to the FDA.

Benzinga

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and…

Benzinga

Hepatitis A Outbreak Linked To Organic Strawberries: What You Need To Know

The U.S. and Canadian governments have traced recent outbreaks of hepatitis A infections to organic strawberries sold at major supermarket chains.

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