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The Latest Breaking News from FDA

Calliditas' Kinpeygo Receives CHMP Backing For Kidney Disease

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional approval for Calliditas Therapeutics AB's (NASDAQ:CALT) Kinpeygo for primary immunoglobulin A (IgA) nephropathy (IgAN). The opinion covers adult patients at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Also See: Calliditas…

Benzinga

Biden's Baby Formula Airlift Stunt Should Never Have Been Necessary

Markets work if you let them. The Biden administration and Congress should remove supply restraints on baby formula that never made any sense in the first place.

Reason

Why is there a baby formula shortage in America? The supply chain and contamination calamity that left parents scrambling

With parents scrambling to track down baby formula and some families even contemplating home-brews, the US government is going to great lengths to solve the spiralling crisis.

ABC News

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

Biden uses Defense Production Act to tackle US baby formula crisis

Government aims to speed production after closure of Abbott plant, as experts urge parents not to concoct own alternatives

The Guardian - US

FDA: Infant formula supply will increase quickly - Roll Call

The Biden administration says it will be 'a few weeks' before the baby food supply around the country is back to normal

Roll Call

Mid-Day Market Update: Nasdaq Rises 100 Points; Cisco Shares Plunge

U.S. stocks traded mixed midway through trading, with the Nasdaq Composite adding 100 points on Thursday.

Benzinga

38 Stocks Moving In Thursday's Mid-Day Session

Gainers NeuroMetrix, Inc. (NASDAQ: NURO) shares climbed 34.6% to $4.1993 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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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

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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The Independent UK

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 Conversation

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.

Benzinga

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

Get all your
news in one place.

100's of premium titles.
One news app.

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:

Bangkok Post

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…

WEKU

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.

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…

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.

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