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The Latest Breaking News from FDA

scPharmaceuticals Shares Are Trading High Following FDA's Acceptance of NDA for FUROSCIX

scPharmaceuticals Inc. (NASDAQ: SCPH) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of the drug candidate FUROSCIX, for the treatment of congestion in patients with worsening heart failure.

Benzinga

FDA Accepts Travere Therapeutics' NDA for Sparsentan with Priority Review

The U.S. Food and Drug Administration (FDA) has accepted Travere Therapeutics’ (NASDAQ: TVTX) New Drug Application (NDA) under Subpart H and granted Priority Review of sparsentan for the treatment of IgA nephropathy (IgAN).

Benzinga

Biden offers logistics support to ease formula shortage

President Joe Biden is offering formula manufacturers and retailers transportation and logistics support to ease the nationwide shortage of baby formula

The Independent UK

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Here's Why Travere Therapeutics Shares Are Rising Today

Travere Therapeutics Inc (NASDAQ: TVTX) shares are trading higher by 7.66% at $23.88 after the company received a priority review from the FDA for its treatment of IgA Nephropathy.

Benzinga

Buffalo Shooting Will Prompt Measures 'To Combat Domestic Terrorism,' Says Pelosi

Plus: Netflix defends artistic expression, perspectives on the baby formula shortage, and more...

Reason

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

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Anti-Vaping Hysteria Is Deadly

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

Reason

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

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

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Chicago Tribune

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.

Reuters

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."

The Independent UK

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

Benzinga

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.

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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

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:

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.

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