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US FDA grants market authorization to six on! PLUS nicotine pouch products
20 Dec 2025 01:45 GMT
… the pilot program that the FDA launched in September, and applies … the United States.
The FDA said its decision was based … receive market authorization from the FDA in the U.S.
… invested heavily in developing and marketing alternatives to cigarettes as demand …
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Trump's FDA sends warning letters to companies selling chest binders
19 Dec 2025 21:43 GMT
… quot; medical devices.
The FDA sent the letters on … States.
In the letters, FDA Director Michael J. Hoffmann claimed … support needed to pass.
FDA Commissioner Marty Makary also announced … marketing of these products for children is alarming. The FDA will …
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Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
19 Dec 2025 21:00 GMT
… Associated with Obstructive HCM FDA Approval Based on Results … . Food and Drug Administration (FDA) has approved MYQORZO™ (aficamten … Time to discuss the FDA approval of MYQORZO. Interested … a positive opinion recommending marketing authorization in the European …
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Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027
19 Dec 2025 19:57 GMT
… Food and Drug Administration (FDA) has provided a written … galectin-3 inhibitor. The FDA converted the Company' … the written response from FDA, Galectin Therapeutics will pursue … regarding development, approval and marketing of any of Galectin…
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BMS’ Cobenfy TV ad is latest target of FDA untitled letter spree
19 Dec 2025 18:29 GMT
… help manage schizophrenia symptoms.
The FDA’s Dec. 15 untitled … both positive and negative.
The FDA noted that trials supporting Cobenfy … not respond to Fierce Pharma Marketing’s request for comment.
… spots and other marketing materials to earn the FDA’s ire …
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FDA Approves GSK’s Twice-Yearly Biologic for Severe Eosinophilic Asthma
19 Dec 2025 17:20 GMT
… in the United States.
The FDA decision is based on results … simplifying long-term management.
The FDA approval follows recent regulatory momentum … . The therapy has already received marketing authorisation from the UK’s …
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Abbott secures FDA and CE Mark approvals for Amplatzer delivery system
19 Dec 2025 17:14 GMT
… US Food and Drug Administration (FDA) and CE Mark approvals for … congenital heart condition.
Discover B2B Marketing That Performs
Combine business intelligence … previously secured CE Mark and FDA approval in 2019.
Abbott structural …
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FDA modernizes medical device evidence requirements
19 Dec 2025 16:00 GMT
… marketing application. Similar updates may follow for drugs and biologics, the FDA … in practice, stringent FDA expectations have limited its … without compromising privacy. FDA reviewers will now evaluate … to patients faster,” FDA Commissioner Marty Makary, MD …
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Galectin Therapeutics Provides Regulatory Update Following FDA Written Response and Announces an Additional $10 Million Line of Credit from Richard E. Uihlein Sufficient to Cover Expected Expenditures Through March 2027
19 Dec 2025 13:00 GMT
… Food and Drug Administration (FDA) has provided a written response … galectin-3 inhibitor. The FDA converted the Company’s initial … stated, “We appreciate the FDA’s written feedback and are … regarding development, approval and marketing of any of Galectin’s …
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FDA Approves Add-On Depemokimab for Severe Asthma
19 Dec 2025 11:49 GMT
The US FDA has approved depemokimab as an … glucocorticoids.
Depemokimab also has received marketing authorization in the UK from …
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