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The Latest Breaking News from FDA

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.

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

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.

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

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

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

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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:

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.

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How to access abortion post-Roe

How to access abortion post-Roe

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

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

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

The Independent UK

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

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.

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

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…

Red states crack down on abortion pills

Red states crack down on abortion pills

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

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

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…

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

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…

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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

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.

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:

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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…

The Independent UK

Next battle over access to abortion will focus on pills

More than half of abortions in America are now done with pills, rather than surgery

Tribune News Service

FDA contradicts Pfizer’s advice on 2nd course of COVID drug

There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help COVID-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.

Tribune News Service

CBD may be getting into milk and eggs from animals, FDA says

U.S. regulators are concerned about the safety of cannabis compounds taken by animals leaching into human foods like milk and eggs.

FDA Issues Warning Letters To Companies Illegally Selling Delta-8 THC, Calls It Dangerous To Consumers

The U.S. Food and Drug Administration issued warning letters to five companies for selling products containing delta-8 THC in ways that violate the Federal Food, Drug, and Cosmetic Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.

The Independent UK

Democrats call on FDA to remove ‘antiquated discriminatory’ limits on gay, bisexual men donating blood amid Canadian decision

Val Demings and Mark Takano tell The Independent the US should also ‘follow science’

TransMedics Stock Skyrockets On Increased 2022 Guidance

TransMedics Group Inc (NASDAQ:TMDX) shares got a massive boost after better than expected Q1 earnings and 2022 guidance. The company posted an EPS loss of $(0.38) in line with expectations and higher than $(0.29) a year ago despite more than doubling its sales from Q1 FY21. Net revenue of $15.9 million increased 125%…

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