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The Latest Breaking News from FDA

Editorial: Biden's move to make cigarettes less addictive is the right fight to have

The Biden administration this week launched a broadside against Big Tobacco in an effort to break its hold over millions of Americans. The Food and Drug Administration on Tuesday announced it will seek a rule forcing dramatic reduction in the amount of nicotine in cigarettes, to render them less addictive…

St. Louis Post-Dispatch

Commentary: Overhyped Alzheimer’s treatments betrayed patients’ hopes. Here’s how science should change

America’s science policies are changing. America’s scientists need to change with them. The recent controversies over the Food and Drug Administration’s accelerated approval of an Alzheimer’s treatment are a lesson in the costs of failing to do so.

Los Angeles Times

US to expand monkeypox testing to large commercial labs

The U.S. plans to start testing for monkeypox at five of the nation’s largest commercial laboratories, broadening its effort beyond government facilities in an effort to address rising case numbers, the Department of Health and Human Services said Wednesday.

Tribune News Service

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Is it safe to use homemade tampons?

In light of the tampon shortage, doctors don't advise turning to this dangerous internet trend

Salon

FDA probing death of another child said to have consumed Abbott baby Formula

Shortage of formula has created more headaches for Biden administration

The Independent UK

The FDA Is Set To Ban Juul Products In U.S.: What Companies Could Benefit?

The U.S.

Benzinga

Woman claims aesthetician found beads from Neutrogena face scrub ‘stuck in’ pores during facial

‘She pulled out multiple Neutrogena beads,’ the TikToker says

The Independent UK

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FDA investigates death of another infant given Abbott formula

U.S. Food and Drug Administration officials are investigating the death of another infant who was given formula made by Abbott Laboratories.

Tribune News Service

You may soon be able to get abortion pills at your local pharmacy

This new FDA rule is a big first for the U.S.

Mic

The FDA knows nicotine is addictive. It wants to regulate it for the first time

The Food and Drug Administration is poised to set a maximum nicotine level in cigarettes and some other tobacco products, looking to make them less addictive and wean smokers off the habit.

WEKU

In a Surprise Move, the FDA Denies Approval for Juul Tobacco and Menthol Vapes

What was once a classic Silicon Valley success story has become the victim of an intensely ideological war on nicotine.

Reason

Krystal Biotech Files To Seek Approval For Skin Disease Candidate

Krystal Biotech, Inc. (NASDAQ: KRYS) submits biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of B-VEC (beremagene geperpavec) in the treatment of patients with dystrophic epidermolysis bullosa (DEB).

Benzinga

Juul e-cigarettes officially banned in the US

The US Food and Drug Administration announced on Thursday that the company ‘must stop selling and distributing these products’

The Independent UK

Biden administration to call for nicotine reductions in cigarettes

New policy forcing tobacco companies to cut nicotine to nonaddictive amounts could upend industry

The Independent UK

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Benzinga

GBS: GBS' Prints Are All Over It

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

Benzinga

The Daily Biotech Pulse: Precision BioSciences Inks Gene Editing Pact, Athira Pharma's Alzheimer's Candidate Fails, Enanta Sues Pfizer Over COVID-19 Antiviral

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

Benzinga

Mustang Bio Shares Gain As FDA Grants Orphan Drug Status To Waldenstrom Drug

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Mustang Bio’s (NASDAQ: MBIO) lead drug MB-106 for the treatment of Waldenstrom macroglobulinemia (WM), a rare type of B-cell non-Hodgkin lymphoma (B-NHL).

Benzinga

Ikena Oncology Secures Fast Track designation From FDA For Pleural Cancer Candidate

Ikena Oncology, Inc. (NASDAQ: IKNA) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for IK-930, in patients with unresectable NF2-deficient malignant pleural mesothelioma (MPM).

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Benzinga

How About Reducing Nicotine Levels In Tobacco Products? Biden Administration Working On Cap Plan

The Biden administration signaled that it would develop a proposed rule to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction, and death.

Axios

Biden administration wants to take the buzz out of cigarettes

The Biden administration wants to make the tobacco industry cut back the amount of addictive nicotine allowed in cigarettes sold in the U.S.

Benzinga

67 Biggest Movers From Yesterday

Gainers Convey Health Solutions Holdings, Inc. (NYSE: CNVY) shares jumped 138.4% to close at $10.30 as the company agreed to be taken private by TPG Capital.

Salon

Does Paxlovid work against COVID?

Experts explain how the drug works, where it came from, and what kinds of side effects to expect

Benzinga

Recap of Tuesday's Biotech Catalysts - End of the Day Summary

Ionis (NASDAQ: IONS) announced that Eplontersen met co-primary and secondary endpoints in interim analysis of the Phase 3 NEURO-TTRansform study for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) Ionis shares are trading low 4 percent at $35.10 in the after-hours session

Benzinga

Paratek Pharmaceuticals' Shares Gain Following FDA Fast Track Designation For Nontuberculous Mycobacterial (NTM) Drug

Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) received Fast Track designation from the U.S.

Benzinga

Kiromic BioPharma's Prioritizes New Gamma Delta T-Cell Product Candidate

Kiromic BioPharma Inc (NASDAQ:KRBP) has announced a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT. Kiromic expects to submit its first new investigational new drug (IND) application to the FDA in 2H of 2022. The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with…

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