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The Latest Breaking News from FDA

Why AcelRx Pharma Shares Are Trading Higher Today?

The FDA has recently modified the AcelRx Pharmaceuticals Inc's (NASDAQ:ACRX) Dsuvia Risk Evaluation and Mitigation Strategies (REMS) requirements for healthcare setting audits. The Dsuvia REMS program aims to mitigate the risk of respiratory depression resulting from accidental exposure by ensuring that DSUVIA is dispensed only to patients in certified medically supervised healthcare settings. In…

Benzinga

Upcoming U.S. FDA Decision A Potentially Major De-Risk Event For Revive Therapeutics

It’s been a long and arduous road for Revive Therapeutics Ltd. (OTC: RVVTF) regarding their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.

Benzinga

New COVID-19 mystery: Some are getting coronavirus again even after taking Paxlovid

Some coronavirus-positive patients who have completed treatment of the anti-COVID drug Paxlovid are rebounding into illness, and experts are urging people to be cautious if they develop COVID-like symptoms again and become infectious.

Los Angeles Times

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New COVID-19 mystery: Some are getting coronavirus again even after taking Paxlovid

Los Angeles Times

Republicans vote "no" on baby food hike

Nine Republicans vote "no" on bill that would help low-income parents access baby food amid shortage

Salon

Mid-Morning Market Update: Markets Open Lower; US Jobless Claims Increase To 218,000

U.S. stocks traded lower this morning, with the Dow Jones dipping more than 300 points on Thursday.

Benzinga

Why NeuroMetrix Shares Are Skyrocketing

NeuroMetrix Inc (NASDAQ: NURO) shares are trading higher by 30.10% at $4.06 after the company announced the FDA has granted De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia.

Benzinga

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FDA faces congressional scrutiny over baby formula shortage

The head of the Food and Drug Administration is facing congressional lawmakers for the first time over the national shortage of baby formula

The Independent UK

Baby formula industry was primed for disaster long before key factory closed down

The conditions that led to a shortage of baby formula were set in motion long before the February 2022 closure of the Similac factory tipped the U.S. into a crisis.

The Conversation

Mersana Stock Gains On FDA Orphan Drug Designation For Gastric Cancer Drug

Mersana Therapeutics, Inc. (NASDAQ: MRSN) received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its drug candidate XMT-2056 or the treatment of gastric cancer. The company is planning to start a clinical study evaluating XMT-2056 for gastric and other cancers.

Benzinga

White House To Prioritize Resources To Increase Production Of Baby Formula

The Biden administration is invoking the Defense Production Act to increase baby formula production, requiring suppliers to prioritize giv

Benzinga

The Daily Biotech Pulse: Valneva's COVID-19 Vaccine Filing Accepted By EMA, Enanta's RSV Candidate Fails, Orphan Drug Tag For Mersana's Gastric Cancer Candidate

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

Benzinga

Cannabis laws to be eased next month

Anyone interested in growing cannabis plants and hemp for home use will be able to do so without having to seek permission from the authorities as of next month, when both plants are due to be removed from the category 5 narcotics list, a Food and Drug Administration (FDA) official…

Bangkok Post

How the U.S. got into this baby formula mess

Just a handful of formula makers dominate the industry so a single plant shutdown can lead to empty shelves.

WEKU

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Tribune News Service

Q&A: A parents’ guide to COVID booster shots for kids 5-11

SAN JOSE, Calif. -- With COVID-19 cases rising again in the Bay Area, parents have a new consideration for protecting their children this week: The Food and Drug Administration granted emergency use authorization Tuesday for kids ages 5-11 to get a booster shot of Pfizer’s COVID-19 vaccine.

Chicago Tribune

The FDA needs more information on supplements. Consumers’ safety is at risk

The COVID-19 quarantine changed everyday life for Americans, including many aspects of our diet, health and exercise regimens. One change that has not received enough scrutiny is that during the pandemic, millions of Americans turned to dietary supplements. In 2020, sales of dietary supplements were 14.5% higher than the previous…

Tribune News Service

Viewpoint 3: To avoid the next infant formula crisis, make food safety a priority

The Food and Drug Administration has reached an agreement with Abbott Laboratories to resume production at the company’s Sturgis, Michigan, facility. The announcement gives hope of relief for the three-fourths of American parents who rely on infant formula, and have struggled to find the product in recent weeks.

Tribune News Service

Viewpoint 2: Cronyism makes the baby formula shortage worse

Bad policy makes people vulnerable, and the current baby formula shortage is just the latest example. The immediate cause of the shortage was contamination in a Michigan factory, which might not resume production until June. But the underlying cause is a slew of bad policies that make the market less…

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WEKU

Biden invokes the Defense Production Act for the baby formula shortage

Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S.

Benzinga

Third Largest Player In Baby Formula Jumps In To Ease Shortage In US

Europe's Nestlé SA (OTC: NSRGF) is ramping up hypoallergenic (HA) baby formula production to alleviate the shortage in U.S. supermarkets.

Benzinga

Aldeyra's Dry Eye Candidate Tops Vehicle In Post-Hoc Analysis Using Computer Automated Grading In Ocular Redness

Aldeyra Therapeutics Inc (NASDAQ:ALDX) reported a post-hoc analysis from the completed Phase 3 TRANQUILITY dry eye chamber trial of reproxalap for dry eye disease. Using computer-automated grading of digital photography from the trial demonstrated statistical significance in favor of reproxalap over the vehicle for the primary endpoint of reducing ocular redness. As previously…

Benzinga

Medical Psychedelics Series In Davos Will Showcase Clinical Efficacy Of Psychedelics To World Economic Forum Attendees

This year, at Davos some of the world’s most prominent psychedelic industry leaders and researchers will attend a satellite event that will run parallel to the World Economic Forum.

Benzinga

EXCLUSIVE: Bexson Biomedical's CSO Says Subcutaneous Ketamine Could Treat Wide Range Of Health Issues

Bexson Biomedical recently signed a deal with the Stevanato Group to develop a subcutaneous delivery system of ketamine.

Benzinga

Applied Molecular Cuts Its Workforce By 40%, Pauses Early-Stage Research Programs

Applied Molecular Transport Inc (NASDAQ:AMTI) will prioritize the advancement of AMT-101 into late-stage clinical development. It is preparing for the end of Phase 2 meetings with the FDA to advance AMT-101 to Phase 3 in chronic pouchitis. Applied Molecular is evaluating the next steps for AMT-126, which recently demonstrated safety and tolerability in…

The Guardian - US

Why is there a baby formula shortage in the US, and what can parents do?

Many parents are struggling to feed their babies, and the crisis is hitting poorer families disproportionately hard

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