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The Latest Breaking News from US Food and Drug Administration

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

5 Dividend Aristocrats To Buy Now

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)…

Biden celebrates ‘huge relief’ for parents as FDA authorises Covid vaccine for young kids

Biden celebrates ‘huge relief’ for parents as FDA authorises Covid vaccine for young kids

‘Today is a day of huge relief for parents and families across America,’ Biden says

The Independent UK

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Abbott again halting baby formula production at its Michigan facility after flooding

Less than two weeks after restarting formula production at its Michigan facility, Abbott has again had to halt manufacturing there amid flooding.

Chicago Tribune

53 Stocks Moving In Thursday's Mid-Day Session

High Hopes For Alcohol Use Disorder Treatment: Clearmind's Successful Pre-IND Meeting With The FDA

The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage.

US Food and Drug Administration lifts clinical hold, Covaxin trials to resume

HYDERABAD: The US Food and Drug Administration (USFDA) has lifted the clinical hold on the Phase 2 and 3 immuno-bridging clinical trials of Bharat Biotech’s Covid-19 vaccine, Covaxin, in the US.

The Times of India

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Abbott Nutrition strikes deal with FDA to restart factory linked to baby formula shortage

Abbott Nutrition strikes deal with FDA to restart factory linked to baby formula shortage

Shelves across US now empty of essential product

The Independent UK

PolarityTE Shares Jump After FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for SkinTE

PolarityTE Shares Jump After FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for SkinTE

The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ: PTE) SkinTE under the its open investigational new drug application (IND).

FDA limits Johnson & Johnson's COVID vaccine to some people due to blood clot risk

FDA limits Johnson & Johnson's COVID vaccine to some people due to blood clot risk

The chances of dying following after receiving the Janssen vaccine is about 1:2,000,000. But with multiple COVID-19 vaccines available, the FDA is limiting the use of the J&J vaccine.

FDA Grants Orphan Drug Designation For IDEAYA's Darovasertib For Uveal Melanoma

FDA Grants Orphan Drug Designation For IDEAYA's Darovasertib For Uveal Melanoma

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to IDEAYA Biosciences (NASDAQ: IDYA) for its drug candidate Darovasertib for the treatment of uveal melanoma.

3 Vaccine Stocks to Buy Following the Surge in COVID-19 Cases in China

3 Vaccine Stocks to Buy Following the Surge in COVID-19 Cases in China

China is battling with its worst COVID-19 outbreak since 2020. Surging cases of a new omicron variant worldwide are raising concerns that another COVID-19 wave is coming, which could drive demand for future vaccine orders. This bodes well for popular vaccine stocks Pfizer (PFE), Moderna (MRNA), and BioNTech (BNTX), and…

US FDA Advisers Say More Data Needed for Cancer Drug Tested in China

US FDA Advisers Say More Data Needed for Cancer Drug Tested in China

A panel of outside advisers to the US Food and Drug Administration on Thursday voted to recommend that Innovent Biologics Inc and Eli Lilly and Co be required to conduct a trial of their lung cancer drug that is applicable to the US population. Data submitted to the FDA for…

Asharq Al-Awsat

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