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The Latest Breaking News from FDA

Why TherapeuticsMD Shares Are Trading Higher Today

TherapeuticsMD Inc (NASDAQ:TXMD) shares are trading higher after FDA approved the supplemental application, including minor revisions to Annovera's in vitro release testing specification that allowed for normal manufacturing variability. The FDA approved Annovera in August 2018 as the only long-lasting, reversible, procedure-free birth control. With the approval of the supplemental application, the company believes…

Benzinga

Mid-Morning Market Update: Markets Open Higher; Deere Tops Q2 Views

U.S. stocks traded higher this morning. Following the market opening Friday, the Dow traded up 0.20% to 31,316.89 while the NASDAQ rose 0.35% to 11,428.90. The S&P also rose, gaining, 0.34% to 3,914.24.

Benzinga

Baby formula shortage shows risk of US industry concentration

Formula isn’t just for babies. April Crohare desperately needs it for her 14-year-old son, Charlie. Due to medical complications from a rare brain disorder called lissencephaly, his only source of nutrition comes from infant formula through a feeding tube.

Tribune News Service

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The Daily Biotech Pulse: CDC Recommends COVID-19 Boosters For Kids 5-11, Foghorn's Blood Cancer Trial On Clinical Hold, Bayer Intends To Bow Out From CAR-T Therapy Pact With Atara

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

Benzinga

CDC Recommends Pfizer/BioNTech COVID-19 Booster Shots For Kids Aged 5-11 Years

The Centers for Disease Control and Prevention recommended that children ages 5 to 11 receive the newly authorized COVID-19 booster shot from Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX). Following the recommendation, many of the nation's doctors, pharmacies, and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children…

Benzinga

Telehealth abortion demand is soaring. But access may come down to where you live

Recent rule changes made it easier for patients to get abortion pills through the mail, using telehealth services. Now there is growing demand for these services – and new legal battles brewing.

WEKU

FDA Places Clinical Hold On Foghorn Therapeutics' Early-Stage Blood Cancer Trial

The FDA has instituted a clinical hold on Foghorn Therapeutics Inc's (NASDAQ:FHTX) Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The FDA initiated the partial clinical hold following the report of a recent death that occurred in a subject with potential differentiation syndrome. Differentiation…

Benzinga

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Baby formula crisis: Abbott enriched shareholders as factory needed repairs, records show

Economists condemn ‘rot’ in system after manufacturer issued billions in stock buybacks despite problems at Michigan factory

The Guardian - US

71 Biggest Movers From Yesterday

Gainers NeuroMetrix, Inc. (NASDAQ: NURO) shares jumped 76.3% to close at $5.50 on Thursday 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

Liberals are blaming Donald Trump for the baby formula shortage, but is that accurate?

Reexamining a trade deal with bipartisan support

The Independent UK

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

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

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Benzinga

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

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…

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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…

Reason

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.

ABC News

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.

The Guardian - US

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

Roll Call

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

Benzinga

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.

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