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The Latest Breaking News from FDA

11 of Kellogg's strangest inventions

Many of the health guru's inventions would fail to find FDA approval today, but a few were ahead of their time

Salon

Thailand's first lot of local Covid vaccine produced

The first batch of ChulaCov19, the first messenger-RNA vaccine developed in Thailand, has been produced and is awaiting Food and Drug Administration (FDA) approval for the first two phases of human trials, a government spokesperson said on Saturday.

Bangkok Post

Texas' abortion law led some to get abortion pills in Mexico, with grim consequences

Since Texas passed its anti-abortion law, more and more women have been getting abortion pills at unregulated pharmacies in Mexican border towns — where they are freely sold without a prescription.

WEKU

From analysis to the latest developments in health,
read the most diverse news in one place.

What overturning Roe means for medication abortion

The fact that there's an FDA-approved drug for use up to 10 weeks and states are saying ‘no, you can only use it for six,’ makes no sense.”

Inverse

ECOR: First Quarter 2022 Financial and Operational Results

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

Benzinga

Worried About a Market Meltdown? Then Buy These 5 Stocks Now

The market’s near-term outlook remains uncertain on concerns over the persistent macroeconomic and geopolitical issues. But we think investors worried about a market meltdown can look to add quality stocks Coca-Cola FEMSA (KOF), CGI (GIB), Novartis (NVS), PLDT (PHI), and Fresenius Medical Care (FMS) to their portfolios because these names…

StockNews.com

U.S. FDA extends review of Pfizer and Myovant Sciences supplemental New Drug Application (sNDA) For MYFEMBREE by three months

The U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) from Pfizer Inc.

Benzinga

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The Daily Biotech Pulse: Limited Use Of JNJ's COVID-19 Shot, Myovant-Pfizer's Relugolix Application Delayed, Gain Therapeutics' Parkinson's Data

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

Benzinga

Morning Brief: Top Financial Stories Dominating on Friday, May 6

Reuters IHG Hotels & Resorts On Way To Recovery As Travel Booms

Benzinga

FDA Limits Use of Johnson & Johnson's COVID-19 Vaccine to Certain Individuals - All You Should Know

The FDA said it was limiting the use of Johnson & Johnson's (NYSE:

Benzinga

US Drug Regulator Limits Use of J&J Covid Vaccine

The US said Thursday only adults who "have personal concerns" about mRNA vaccines, access issues or medical reasons for refusing them may now receive the Johnson & Johnson Covid shot, which has been linked to a rare but serious clotting condition. The vaccine, which was authorized as a single shot,…

Asharq Al-Awsat

FDA limits use of Johnson & Johnson COVID vaccine over blood clot risks, agency says

The use of Johnson and Johnson’s COVID-19 vaccine, also known as Janssen, has been limited to “certain individuals” over rare blood clot risks, the U.S. Food and Drug Administration announced Thursday, May 5.

McClatchy Washington Bureau

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.

WEKU

How to access abortion post-Roe

An individual states' ban cannot prevent you from getting an abortion in other ways and through other states

Salon

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The Independent UK

FDA restricts J&J's COVID-19 vaccine due to blood clot risk

U.S. regulators are strictly limiting who can receive Johnson & Johnson’s COVID-19 vaccine due to a rare but serious risk of blood clots

Benzinga

FDA Berates Pfizer CEO's Suggestion To Take More Paxlovid If COVID-19 Symptoms Rebound

The FDA berates Pfizer Inc (NYSE: PFE) CEO Albert Bourla's proposed solution in cases where virus levels rebound after the first course of treatment.

Benzinga

BioCryst's Voluntary Pause Of Rare Blood Disorder Trial Turns Into FDA Clinical Hold

Tucked in its Q1 earnings release, a voluntary pause for BioCryst Pharmaceuticals Inc's (NASDAQ:BCRX) complement-mediated disease therapy has been upgraded to a partial FDA clinical hold. The update clarified why the company paused trials testing BCX9930 in patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder marked by the destruction of red blood cells…

Axios

Red states crack down on abortion pills

Several states have moved to restrict access to the pills and more could follow suit.

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news in one place.

100's of premium titles.
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Benzinga

Novavax Seeks Approval For COVID-19 Shot Among Adolescents In Britain

Novavax Inc (NASDAQ:NVAX) filed an application with Britain's drugs regulator for the authorization of its COVID-19 vaccine among adolescents aged 12 and older. Britain had in February cleared the two-dose vaccine, Nuvaxovid, for use in adults. Novavax's submission includes data from a late-stage trial in the U.S., where the vaccine showed 80% efficacy among…

Benzinga

FDA Approval For AstraZeneca - Daiichi's Enhertu Expands To Earlier Use In Metastatic Breast Cancer

The FDA has approved AstraZeneca plc (NASDAQ:AZN) and Daiichi Sankyo's (OTC:DSKYF) Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive breast cancer. The approval covers patients who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within…

Los Angeles Times

Abortion pills: A post-Roe game-changer — and the next battleground

WASHINGTON — The future of abortion in the U.S. is moving to the mailbox.

The Guardian - US

Don’t believe the high: FDA issues warning over misleading legal weed claims

Food and Drug Administration warns against unproven health claims of delta-8 THC and packaging that appeals to children

Benzinga

22nd Century Group Reports Q1 Net Sales Of $9M, Up 33% YoY, Net Loss Also Grows

22nd Century Group, Inc. (NASDAQ: XXII) reported results for the first quarter ended March 31, 2022.. The company will host a live audio webcast on May 5, at 10:00 a.m. ET.

Benzinga

The Daily Biotech Pulse: AstraZeneca's 3 Product Updates, Jazz Pharma Licenses Sleeping Disorder Product, Argenx Aces Bleeding Disorder Study

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

Los Angeles Times

Commentary: COVID won’t become endemic until we have a vaccine for kids under 5

Last week, Moderna became the first manufacturer to officially ask the Food and Drug Administration to approve its COVID-19 vaccine for children under 6 years old. One of three companies with authorized COVID-19 vaccines in the United States, Moderna made the request a month after saying its data showed efficacy…

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