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The Latest Breaking News from FDA

Markets Finish Lower Following Wednesday's Intense Sell-Off

U.S. indices finished Thursday's trading session lower. Worse-than-expected retail earnings and anticipation of further Federal Reserve policy tightening in 2022 have continued to weigh on stocks across sectors.

Benzinga

Abbott baby formula factory could reopen by next week, FDA head says

An Abbott baby formula plant in Michigan that’s been shut down since February could be up and running as early as next week, the head of the Food and Drug Administration told lawmakers Thursday.

Tribune News Service

US baby formula crisis: What you need to know

Why is there an infant formula shortage in the US? Who is to blame? And when will parents see relief?

Al Jazeera

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FDA head says baby formula factory could reopen in the next week or two

But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.

WEKU

Pfizer, NIH Mulling Study For Longer Paxlovid Course To Combat Reinfections

The U.S. National Institutes of Health and Pfizer Inc (NYSE:PFE) are discussing testing a longer course of COVID-19 antiviral treatment Paxlovid, required to prevent reinfections, White House Chief Medical Officer Anthony Fauci said. "We're going to be planning what studies we're going to be doing relatively soon, within the next few days," to…

Benzinga

Abbott's Troubled Baby Formula Michigan Plant To Reopen In 1-2 Weeks: Reuters

Abbott Laboratories (NYSE:ABT) and the FDA are reportedly on track to reopen the company's Sturgis, Michigan, baby formula manufacturing plant within one or two weeks, FDA Commissioner Robert Califf said. Abbott, the biggest U.S. supplier of powder infant formula, including Similac, agreed with the FDA on the steps needed to resume production at…

Benzinga

Immunome Shares Rise After Publishing Positive COVID-19 Antibody Cocktail Data

Immunome Inc (NASDAQ:IMNM) shares are trading higher after it published data demonstrating that its COVID-19 antibody cocktail, IMM-BCP-01, potently cleared the omicron variant (BA.1) when tested in vivo in hamsters. Additional in vitro testing of a SARS-CoV-2 pseudovirus showed that IMM20253, one of the antibodies in Immunome's cocktail, successfully neutralized the omicron subvariant…

Benzinga

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Why SIGA Technologies Shares Are Trading Higher Today?

The FDA approved the intravenous (IV) formulation of SIGA Technologies Inc's (NASDAQ:SIGA) TPOXX for smallpox. The oral formulation of TPOXX (tecovirimat) is approved in the US, Canada, and Europe to treat smallpox. The European approval also includes the treatment of monkeypox, cowpox, and complications from immunization with vaccinia. The IV formulation of TPOXX was…

Benzinga

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

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

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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

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.

Los Angeles Times

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.

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Los Angeles Times

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

Salon

Republicans vote "no" on baby food hike

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

Benzinga

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.

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.

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