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The Latest Breaking News from FDA

A drug for pregnant women doesn’t work, according to the FDA. A company is selling it anyway

LOS ANGELES — American babies are at far higher risk of dying before their first birthdays than those in almost any other wealthy country. A big reason for those deaths, more than 21,000 each year, is that too many are born too soon.

Los Angeles Times

Mayo Clinic expert stresses importance of vaccinating school-age children for COVID-19

Parents hoping to get their young children vaccinated for COVID-19 will have to wait at least another two months. The Food and Drug Administration (FDA) recently postponed a decision on an emergency use authorization of the Pfizer vaccine for kids 6 months to 4 years old. The FDA is waiting…

Tribune News Service

Family Dollar recalls food, drugs and other products in 6 states after FDA inspection finds rodents

Family Dollar recalled all medical devices, cosmetics, dietary supplements, drugs and food for people and pets shipped since Jan. 1, 2021, to 404 stores after an FDA inspection found “insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated.”

McClatchy Washington Bureau

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FDA issues warning for Family Dollar stores after 1,100 rodents found at Arkansas facility

The states impacted include Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee

The Independent UK

The Federal Tap: Congressman Jim Hagedorn (R) passes away

Our weekly summary of federal news updates you on Congressman Jim Hagedorn’s (R) recent death and the newest congressional districts in Minnesota. Read all about it in this week’s edition of the Federal Tap.

Ballotpedia

Ivermectin, hailed as Covid wonder drug by Trump fans, does not prevent severe illness, study finds

Study casts doubt on efficacy of antiparasitic drug in preventing progression to severe disease in Covid patients

The Independent UK

Trade Restrictions on Oysters Get Shucked

After more than a decade on ice, trade in shellfish between the European Union and the United States is about to pick up steam.

Reason

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See Why Did FDA Update Merck's COVID-19 Pill Emergency Use Authorization

The FDA has revised the Emergency Use Authorization (EUA) for Merck & Co Inc's (NYSE: MRK) COVID-19 pill mo

Benzinga

Medtronic Scores Expanded FDA Nod For Cardiac Cryoablation Catheters In Pediatric Patients With Heart Rhythm Condition

The

Benzinga

Psychedelics Are Transforming The Future Of Mental Healthcare – Can It Do The Same For Personal Wellness?

by Matt Stang, Founder & CEO of DELIC

Benzinga

Atara Biotherapeutics Shares Fall After Reporting Patient Death In ATA2271 Autologous CAR T Trial

Memorial Sloan Kettering Cancer Center's (MSK) has notified the FDA of a fatal serious adverse event (SAE) associated with a patien

Benzinga

FDA Asks For More Data To Resolve BioMarin's Gene Therapy Clinical Hold

BioMarin Pharmaceutical Inc (NASDAQ: BMRN) said that the

Benzinga

Baby formula recalled over bacteria fears after baby dies

FDA says four children were hospitalised with illness, and one of them later died

The Independent UK

The Daily Biotech Pulse: Regeneron-Sanofi Halt Late-Stage Dupixent Study, Agios Gets FDA Nod, Safety Scare For GSK's RSV Vaccine, Shockwave Jumps On Earnings

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

Benzinga

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Benzinga

FDA Approves Agios' Mitapivat As First Disease-Modifying Therapy For Genetic Blood Disorder

The

McClatchy Washington Bureau

FDA says official suggesting annual COVID vaccines ‘does not work on vaccine matters’

A video has emerged of a Food and Drug Administration executive suggesting there are plans for annual COVID-19 vaccines to be implemented in the United States.

The Independent UK

Parents spark breakthrough gene therapy for devastating child disease ignored by big pharma

Exclusive: For more than a century there has been no cure, no treatment and no hope for children diagnosed with Tay-Sachs disease. Now grassroots campaigns to fund research are on the brink of delivering a breakthrough, Io Dodds reports

Benzinga

Apyx Medical Submits Additional FDA 510(k) For Expanded Use Of Renuvion In Dermatological Procedures

Apyx Medical Corporation (NASDAQ: APYX) announced the publication of an article in a journal featuring the results of its U.S. IDE study evaluating the Renuvion Dermal Handpiece using Apyx's Helium Plasma Technology for dermal resurfacing procedures.

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Benzinga

FDA Sets Up Adcomm To Review Amylyx's ALS Drug Next Month

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) marketing application for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol)

Benzinga

The Daily Biotech Pulse: J&J Unit Announces Research Collaboration With Remix, Regencell Touts COVID Data, Decision Day For Agios

Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Amylyx's ALS Treatment Regulatory Application To Be Reviewed By FDA Panel In Late March

Tribune News Service

Inside the tactical tug of war over the controversial Alzheimer’s drug

The drug industry, patient advocates and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism and discrimination against the disabled — and hinted at a lawsuit — over the…

Benzinga

Outset Medical More Than Doubles Sales In FY21, Issues Better Than Expected FY22 Outlook

Outset Medical Inc (NASDAQ:OM) recorded Q4 FY21 net revenue of $28.2 million, a 63.2%, beating the consensus of $26.42 million. Product revenue for the fourth quarter of 2021 was $23.7 million, +79.5%. The Company achieved a gross margin of 11.8%, compared to 2.4% in the fourth quarter of 2020 Select Development: The…

Benzinga

ATE.TO: First Human PK/PD Studies Underway in Otenaproxesul's Post-Operative Pain Program…

By David Bautz, PhD OTC:ATBPF | TSX:ATE.TO READ THE FULL ATE.TO RESEARCH REPORT

Benzinga

US Senate Narrowly Votes In Favor Of Biden's Nominee Robert Califf To Lead FDA For Second Time

By a narrow vote of 50-46, the Senate has confirmed Robert Califf to run the FDA.

Benzinga

Mirati Therapeutics' Adagrasib Application Under FDA Review For Lung Cancer Setting

The

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