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The Latest Breaking News from FDA

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…

Benzinga

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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…

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).

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.

Benzinga

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

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

The Independent UK

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…

Benzinga

The Daily Biotech Pulse: Thumbs Down For Acadia's Pimavanserin, Pfizer Buys Stake In Valneva, AstraZeneca - Ionis Eplontersen Aces Rare Disease Trial

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

Benzinga

5 Dividend Aristocrats To Buy Now

Last week, the Fed raised its benchmark interest rates three-quarters of a percentage point, marking the most aggressive hike since 1994. And with analysts predicting the economy to slip into a recession, we think dividend aristocrats Abbott (ABT), AbbVie (ABBV), Genuine Parts (GPC), Johnson & Johnson (JNJ), and Sysco (SYY)…

StockNews.com

You're probably applying sunscreen wrong. Skincare experts explain how to best use it.

From chemical to mineral sunscreens to SPF and UPF ratings, here's how you should be using sunscreen.

Inverse

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Tribune News Service

What you need to know about COVID vaccines for kids under 5

COVID-19 vaccines for children under 5 years old were authorized by the U.S. Food and Drug Administration on Friday and by the Centers for Disease Control and Prevention on Saturday, a welcome relief to parents of the last age group to become eligible for shots.

Tribune News Service

A proposal to import drugs from other countries creates an unusual alliance in the Senate

Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders, I-Vt., and Rand Paul, R-Ky.

Miami Herald

Doctors ‘thrilled’ to order COVID vaccines for young kids after DeSantis changes course

MIAMI — Pediatricians across Florida have begun ordering COVID-19 vaccines for their patients under 5 after Gov. Ron DeSantis changed course Friday and allowed doctors and hospitals in the state to get them from a federal program.

Chicago Sun-Times

COVID shots for infants, preschoolers OKed to begin in the coming week

The approval Saturday from Dr. Rochelle Walensky, the CDC’s director. expands the nation’s coronavirus vaccination campaign to children as young as 6 months old.

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Axios

Kids under 5 can get COVID vaccines next week after CDC approval

CDC Director Walensky has agreed with the recommendation the Moderna and Pfizer shots be given to children as young as six months old.

The Guardian - US

CDC recommends Covid vaccines for infants, toddlers and preschoolers

Children as young as six months will be able to get shots from either Pfizer or Moderna after Friday’s FDA approval

The Independent UK

US children under five may receive Covid vaccine from next week after CDC gives rollout green light

‘We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,’ says CDC Director Dr Rochelle Walensky

The Independent UK

CDC advisers recommend COVID-19 shots for children under 5

U.S. health advisers have recommended COVID-19 vaccines for infants, toddlers and preschoolers — the last group without the shots

Chicago Sun-Times

FDA approves COVID-19 shots for children under 5

U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots.

WEKU

The FDA authorizes COVID-19 shots for infants and preschoolers

The vaccinations for children as young as 6 months old could start next week. But first, the Centers for Disease Control and Prevention must sign off.

Tribune News Service

With COVID shots approved for toddlers, here’s what you need to know

The U.S. Food and Drug Administration authorized COVID-19 vaccines for children under 5 years old Friday, a welcome relief to parents of the last age group to become eligible for shots. Although the move will help protect children from infection and serious disease, vaccine hesitancy still looms in the U.S.…

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