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Category Fda

CNBC Business • 02/13/2026 • Free

What signal Lilly sends by stockpiling its GLP-1 weight loss pills ahead of FDA approval

Lilly’s accumulation of GLP-1 weight loss pills prior to FDA approval indicates strategic preparation for potential high demand, which could significa...

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MarketWatch Top Stories • 02/11/2026 • Free

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

Moderna’s inability to secure FDA review for its flu vaccine could delay its seasonal vaccine rollout, potentially impacting its revenue growth and in...

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CNBC Business • 02/10/2026 • Free

Moderna says FDA refuses to review its application for experimental flu shot

The FDA's refusal to review Moderna's mRNA-1010 application may delay the company's potential revenue growth from the experimental flu shot and impact...

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CNBC Business • 02/09/2026 • Free

FDA says Novo Nordisk's TV ad for obesity pill includes 'false or misleading' claims

The FDA's request to halt misleading advertisements may impact Novo Nordisk's marketing strategy and potentially affect the sales performance of its o...

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MarketWatch Top Stories • 02/06/2026 • Free

Novo Nordisk stock climbs out of hole on FDA chief’s threat to block Hims and Hers pill

Novo Nordisk's stock rise reflects investor optimism about the FDA's potential support, which could strengthen the company's market position against r...

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Sydney Morning Herald Biz • 01/16/2026 • Free

ASX Runners of the Week: Zelira, Linq, Dalaroo and Osteopore

Zelira Therapeutics secured a $33 million investment aimed at accelerating the development and regulatory review of its autism treatment, highlighting...

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Business Insider Markets • 01/12/2026 • Free

EQS-News: REMSleep Outlines Q1 2026 Commercial Strategy: Expanded FDA Application, B2B Launch Prep, and Institutional Market Entry

REMSleep’s planned regulatory advancements and targeted entry into business and institutional sectors during the first quarter of 2026 are expected to...

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City A.M. • 01/05/2026 • Free

HELUS Pharma Propels Therapeutic Innovation in Mental Health and Commences Trading on Nasdaq

Helus Pharma’s listing on major stock exchanges enhances its ability to secure capital and advance its pipeline, supporting the commercialization of i...

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CNBC Business • 01/01/2026 • Free

Novo Nordisk enters 2026 on the defense as it faces a ‘must-win’ battle in the U.S. market

The FDA's approval of Wegovy underscores critical challenges and opportunities Novo Nordisk must navigate in the U.S. market, impacting its financial...

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Economic Times Markets • 12/24/2025 • Free

Agios Pharma shares jump 16% as US FDA expands approval for blood disorder drug

The expanded FDA authorization for Agios Pharmaceuticals' medication is expected to positively impact the company’s revenue potential and investor con...

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CNBC Business • 12/23/2025 • Free

Shares in Wegovy-maker Novo Nordisk pop 7% after GLP-1 pill approval

The FDA’s approval of Novo Nordisk’s new GLP-1 pill is expected to positively impact the company’s market value and investor confidence due to its pot...

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CNBC Business • 12/22/2025 • Free

FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk

The FDA’s approval of Novo Nordisk’s oral GLP-1 medication for obesity provides the company a competitive advantage in the growing weight-loss drug ma...

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MarketWatch Top Stories • 12/18/2025 • Free

Eli Lilly, Novo Nordisk file competing new weight-loss drugs with the FDA that could be game changers in obesity medicine

Eli Lilly and Novo Nordisk have submitted new obesity treatments to the FDA, potentially impacting market dynamics and investor interests within the g...

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CNBC Business • 12/15/2025 • Free

FDA approved a $250,000 Singapore work trip during government shutdown, records show

During the government shutdown, the agency allocated a substantial budget to fund an overseas conference for multiple employees, highlighting concerns...

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Business Insider Markets • 12/10/2025 • Free

Serina Therapeutics Submits Complete Response to FDA Clinical Hold Letter for SER-252 Program

Serina Therapeutics' response to regulatory concerns may influence its development timeline and investor confidence, potentially affecting funding all...

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Investopedia • 12/01/2025 • Free

FDA Plans to Tighten Vaccine Approvals Weigh on These Stocks

The anticipated regulatory changes regarding vaccine approvals are expected to influence market performance and investor confidence in companies invol...

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MarketWatch Top Stories • 12/01/2025 • Free

Vaccine stocks take a hit as FDA official points to link between COVID-19 vaccines and rare heart condition in young men

Shares of companies producing immunization products declined after a regulatory representative highlighted a possible association between certain vacc...

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Business Insider Markets • 11/13/2025 • Free

SCIENTURE Reports Q3 2025 Financial Results and Provides Business Update

SCIENTURE’s third-quarter results reveal considerable improvements in revenue and gross profit, highlighting the positive impact of introducing a nove...

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City A.M. • 11/06/2025 • Free

Prothena Reports Third Quarter 2025 Financial Results and Business Highlights

Prothena reported substantial cash outflows totaling $140.4 million in the first nine months of 2025, maintaining a strong cash position of $331.7 mil...

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City A.M. • 11/04/2025 • Free

Compass Pathways Announces Third Quarter 2025 Financial Results and Business Highlights Including Acceleration of Commercial Launch Plans by 9-12 Months

The company’s strengthened cash reserves and progress in regulatory discussions enable an expedited commercialization timeline, potentially enhancing...

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CNBC Business • 10/29/2025 • Free

FDA to speed up approvals of generic biologic medicines as Trump targets high drug costs

Accelerating the approval process for biosimilar medications may reduce expenses for consumers while potentially impacting the revenue streams of esta...

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Business Insider Markets • 10/23/2025 • Free

Silo Pharma Issues Update on Milestone Achievements in PTSD Drug Development and New Digital Assets Treasury Program

Silo Pharma’s progress in advancing its PTSD treatment and expanded acquisition of digital assets may positively impact its financial positioning ahea...

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Business Insider Markets • 10/20/2025 • Free

Cogent Biosciences Announces FDA Breakthrough Therapy Designation for Bezuclastinib

The FDA’s recognition of bezuclastinib as a breakthrough therapy may enhance its market potential and investment appeal, potentially leading to increa...

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Business Insider Markets • 10/14/2025 • Free

BVIâs FINEVISION® HP Gains FDA Approval, Ushering in a New Era of Advanced Trifocal IOLs for U.S. Patients

The FDA’s clearance of BVI’s latest intraocular lens system is expected to enhance the company’s market presence and drive potential revenue growth in...

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Business Insider Markets • 10/09/2025 • Free

FDA-Compliant Molecular Marking Positions SMX to Dominate the $824B Global Recycling Market (NASDAQ: SMX)

By implementing approved molecular marking technology, SMX is strategically positioned to capture a significant share of the rapidly expanding global...

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Business Insider Markets • 09/30/2025 • Free

Umoja Biopharma Announces that UB-VV111 Receives FDA Fast Track Designation for Relapsed/Refractory B-Cell Malignancies

The FDA’s expedited review status for Umoja Biopharma’s latest treatment candidate may accelerate development timelines and enhance potential market o...

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Business Insider Markets • 09/30/2025 • Free

OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update

OS Therapies’ strategic adjustment in the submission timeline for OST-HER2 regulatory approvals may accelerate market entry in key regions, potentiall...

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Business Insider Markets • 09/29/2025 • Free

IO Biotech Provides Update Following Pre-BLA Meeting with FDA

IO Biotech’s financial prospects may be influenced as the FDA’s advice to withhold the current application prompts additional investment in new clinic...

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CNBC Business • 09/10/2025 • Free

Healthy Returns: New FDA rules affect copycat GLP-1s, and Apple adds health tools to its latest Watch

The FDA’s recent regulations targeting compounded GLP-1 medications could impact market dynamics, while Apple’s introduction of enhanced health featur...

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CNBC Business • 08/27/2025 • Free

FDA approves new Covid shots with limits on who can get them under RFK Jr.

The recent authorization of updated Covid vaccines may influence insurance coverage policies and affect the availability of these shots for individual...

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