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The Latest Breaking News from FDA

Chimerix Shares Plummet After Divesting Its Only Marketed Product For Over $300M

Emergent BioSolutions Inc (NYSE:EBS) has agreed to acquire Chimerix Inc's (NASDAQ:CMRX) exclusive worldwide rights to Tembexa (brincidofovir), the first FDA-approved antiviral for all age groups for smallpox. "It exemplifies our thoughtful M&A strategy as part of our 2024 growth plan and positions us better to deliver value for our shareholders," said Robert Kramer, president…

Benzinga

Why Eli Lilly Shares Are Trading Higher Today

The FDA approved Eli Lilly And Co's (NYSE:LLY) injected drug tirzepatide, which has the brand name Mounjaro (tirzepatide), to help improve blood sugar control in adults with type 2 diabetes. The approval covers tirzepatide as an adjunct to diet and exercise. As the first and only FDA-approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1…

Benzinga

Anti-Vaping Hysteria Is Deadly

We're repeating the mistakes of the war on drugs.

Reason

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

Morning Brief: Top Financial Stories Dominating on Monday, May 16

CNBC Volkswagen CEO Shares Ambitious EV Ambitions For US Market

Benzinga

Vapers warned they 'are inhaling potentially dangerous levels of synthetic chemicals'

Little is known about the content of synthetic coolants in e-cigarettes or their health risks

Wales Online

Bette Midler faces backlash for telling mothers to ‘try breastfeeding’ their babies amid formula shortage

‘What a profoundly offensive and ignorant statement’

The Independent UK

Baby-formula shortage spurs US to prod Abbott over access

WASHINGTON — The Biden administration on Friday urged Abbott Laboratories to do more to ensure low-income families on federal assistance have access to baby formula, amid a nationwide shortage.

Tribune News Service

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White House bolsters efforts to get baby formula into the hands of WIC recipients

States have been asked to increase accessibility of baby formula for recipients of the low-income program. And the Food and Drug Administration is looking at ways to make it easier to import formula.

WEKU

Why there is a baby formula crisis and what can be done about it

The formula shortage may continue for months.

Axios

After baby formula recall, Abbott says it can restart production at Michigan site within 2 weeks of FDA approval

Abbott Laboratories said it could have some of its recalled infant formulas back on store shelves within eight to 10 weeks after the U.S. Food and Drug Administration gives its approval, though it’s unclear when that approval may come.

Chicago Tribune

Imported infant formula could help lift U.S. supply in weeks -FDA chief

The Food and Drug Administration will outline a plan next week to streamline imports of infant formula, the agency's chief said on Friday, adding that the action along with others would "help dramatically improve the supply in the U.S. in a matter of weeks."

Reuters

House Oversight Committee launches probe into baby formula manufacturers amid nationwide shortage

‘The national formula shortage poses a threat to the health and economic security of infants and families in communities across the country,’ lawmakers write

The Independent UK

Has Clearmind Developed A Psychedelics-Based Drug That Can Treat Alcoholism? The FDA Is Interested

On Wednesday, May 18, Clearmind Medicine Inc. (OTC Pink: CMNDF) will meet with the Center for Drug Evaluation and Research (CDER), a department within the FDA.

Benzinga

56 Stocks Moving In Friday's Mid-Day Session

Gainers Veru Inc. (NASDAQ: VERU) shares jumped 62.5% to $14.67 after the company reported quarterly results on Thursday. Jefferies maintained Veru with a Buy and raised the price target from $33 to $55.

Benzinga

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Benzinga

Amid Slowing Sales at Home, Innovent Biologics Stumbles Overseas

Key takeaways: Innovent Biologics terminated a plan to sell its bevacizumab biosimilar in North America with a local partner after trials for the drug fell behind schedule The company’s loss tripled last year on growing competition for its core product, whose sales fell 22% in this year’s first-quarter

Benzinga

ACHV: First Quarter 2022 Results

By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT

Benzinga

PolarityTE Shares Jump After FDA Regenerative Medicine Advanced Therapy Designation (RMAT) for SkinTE

The U.S. Food and Drug Administration (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PolarityTE’s (NASDAQ: PTE) SkinTE under the its open investigational new drug application (IND).

Benzinga

The Daily Biotech Pulse: FDA Orphan Drug Tags For Neurocrine, Editas Candidates; Sale of BridgeBio's PRV; RMAT Designation For PolarityTE's Product

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

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news in one place.

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Tribune News Service

Tainted baby-formula risk was seen months before Abbott’s recall

Federal inspectors spotted the potential for baby formula made at an Abbott Laboratories plant to become contaminated months before a recall that exacerbated a nationwide shortage, a government document shows.

Reason

How Bad Government Policy is Fueling the Infant Formula Shortage

Trade restrictions and over-zealous FDA regulation are a big part of the problem, but there's more.

Benzinga

23 Stocks Moving in Friday's Pre-Market Session

Gainers OTR Acquisition Corp. (NASDAQ: OTRA) rose 88.7% to $18.21 in pre-market trading after filing on Thursday showed shareholders approved merger with Comera Life Sciences.

Benzinga

90 Biggest Movers From Yesterday

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) surged 70.5% to close at $0.1330 on Thursday after declining 9% on Wednesday. Allena Pharmaceuticals recently reported a $2.8 million registered direct offering.

WEKU

How medication abortion works and what the end of Roe v. Wade could mean for it

More people seeking abortions are turning to abortion pills rather than surgical abortion. Here's what to know about the pills, which will likely be at the center of the abortion battles ahead.

The Guardian - UK

UK ministers ‘picking number out of air’ for civil service job cuts, says union

Headcount reduction of 90,000 civil servants is ‘unrealistic’ and poor way to manage government, says FDA union chief

ABC News

US parents swap and sell baby formula amidst country-wide shortage

A US-wide baby formula shortage forces frenzied parents into online groups to swap and sell to each other to keep their babies fed.

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