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The Latest Breaking News from FDA

LogicBio Therapeutics Shares Skyrocket As FDA Lifts Clinical Hold On Its Pediatric Trial

The FDA has lifted the clinical hold on LogicBio Therapeutics Inc's (NASDAQ:LOGC) LB-001 Investigational New Drug Application (IND) to resume patient enrollment in Phase 1/2 SUNRISE trial in pediatric methylmalonic acidemia patients. Methylmalonic acidemia is an inherited disorder in which the body cannot process certain proteins and fats (lipids) properly. The FDA acknowledged that…

FDA Lifts Clinical Hold on LogicBio Therapeutics' IND for LB-001 in pediatric patients with Methylmalonic Acidemia

FDA Lifts Clinical Hold on LogicBio Therapeutics' IND for LB-001 in pediatric patients with Methylmalonic Acidemia

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on LogicBio Therapeutics’ (NASDAQ: LOGC) Investigational New Drug Application (IND) of its drug candidate LB-001 for pediatric patients with methylmalonic acidemia.

Ask the Pediatrician: What can parents do about baby formula shortage?

Q: There’s been a shortage of baby formula at the grocery stores and I’m starting to worry about running out. What can I do?

Tribune News Service

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The US FDA has moved to ban menthol cigarettes. Australia should do that and more

Menthol is the minty cigarette ingredient that conjures up images of beaches, snow-covered ski slopes and glamorous yacht parties, all crisp white and fresh green. Menthol as a deadly additive is under threat at last.

The Conversation

What’s in your dietary supplements could be secretly hurting you

What are these hidden substances, and why do they matter? Supplements for weigh loss and erectile dysfunction harbored dangerous and even banned drugs.

‘Please pay attention’: Scientist flagged heart-pill toxins early on

A scientist at a China-based company that makes crucial ingredients for generic drugs warned a year before the start of a global recall that some blood-pressure pills could become tainted with potentially cancer-causing chemicals, according to court documents.

Tribune News Service

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

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Thailand's first lot of local Covid vaccine produced

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.

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.

What overturning Roe means for medication abortion

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.”

ECOR: First Quarter 2022 Financial and Operational Results

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

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

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…

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

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.

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

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

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:

Asharq Al-Awsat

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,…

McClatchy Washington Bureau

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.

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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.

How to access abortion post-Roe

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

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

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

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

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 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…

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