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The Latest Breaking News from FDA

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

From analysis to the latest developments in health,
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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).

Benzinga

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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.

Benzinga

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.

Axios

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.

Benzinga

US seeks to drastically cut nicotine content in cigarettes

Washington (AFP) - President Joe Biden's administration on Tuesday announced it would develop a new policy requiring cigarette producers to reduce nicotine to non-addictive levels -- a move that would deal a powerful blow to the tobacco industry.

AFP

Does Paxlovid work against COVID?

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

Salon

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

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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…

Benzinga

FDA Rejects Acer Therapeutics - Relief Therapeutics' Urea Cycle Disorder Candidate

The FDA issued a Complete Response Letter regarding the marketing application for Acer Therapeutics Inc (NASDAQ:ACER) and its collaboration partner, Relief Therapeutics Holding SA's (OTC:RLFTF) ACER-001 (sodium phenylbutyrate), for urea cycle disorders (UCDs). The CRL states: "[The FDA's] field investigator could not complete inspection of [Acer's third-party contract packaging manufacturer] because the facility was not ready…

AFP

US to drastically reduce nicotine content in cigarettes: reports

Washington (AFP) - President Joe Biden's administration is set to announce a new policy requiring cigarette producers to reduce nicotine to non-addictive levels, US media reported Tuesday -- a move that would deal a powerful blow to the tobacco industry.

Benzinga

Acer Therapeutics' Stock Down As FDA Rejects Inborn Metabolism Disorder (UCD) Candidate

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Acer Therapeutics’ (NASDAQ: ACER) New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs).

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news in one place.

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Benzinga

45 Stocks Moving In Tuesday's Mid-Day Session

Gainers Convey Health Solutions Holdings, Inc. (NYSE: CNVY) shares jumped 138.8% to $10.31 as the company agreed to be taken private by TPG Capital,.

Benzinga

Nuvectis Pharma Gets FDA Nod For Initial-Stage Ovarian Cancer Study

The U.S. Food and Drug Administration (FDA) cleared Nuvectis Pharma’s (NASDAQ: NVCT) Investigational New Drug Application (IND) for NXP800, which includes the Phase 1 clinical trial protocol.

The Independent UK

Biden administration to call for nicotine reductions in cigarettes (OLD)

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

Benzinga

Regulus Gets FDA Orphan Drug Status For Kidney Disease Candidate

Regulus Therapeutics Inc. (NASDAQ: RGLS) received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead drug RGLS8429 in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Benzinga

Why AbbVie Stock Is Trading Higher Today

AbbVie Inc (NYSE: ABBV) shares are trading higher Tuesday after the company announced it submitted a supplemental New Drug Application for atogepant to the U.S. Food and Drug Administration to support the preventive treatment of chronic migraine in adults.

Benzinga

Ocugen's Partner COVID-19 Vaccine Covaxin Shows Encouraging Action In Children Below 18 Years

Ocugen Inc (NASDAQ:OCGN) announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for COVID-19 vaccine, Covaxin (BBV152), in The Lancet Infectious Diseases. Covaxin is developed and manufactured by Ocugen's India-based partner Bharat Biotech International Limited. It is under clinical investigation by Ocugen in the U.S. for use…

Investors Business Daily

Acadia Pharmaceuticals Crashes After FDA Panel Votes Down Its Alzheimer's Psychosis Drug

FDA experts voted against Acadia Pharmaceuticals' Alzheimer's disease psychosis drug, leading ACAD stock to plummet.

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