Latest News for: us fda

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Lupin gets USFDA nod for generic drug to treat seizures

Business Line 25 Feb 2026
Lupin receives USFDA ...
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Biocon wins USFDA approval for generic weight-loss drug Liraglutide

Business Line 25 Feb 2026
Approval marks Biocon’s entry into the high-growth US obesity treatment market ....
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USFDA clears Dr Reddy’s licence application for biosimilar to Orencia

Business Line 21 Feb 2026
The proposed drug is intended for the treatment of arthritis ....
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US FDA reverses course, will review Moderna's flu vaccine

The Times of India 18 Feb 2026
The FDA will consider full approval for adults aged 50 to 64.
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US FDA reverses decision and agrees to review Moderna’s flu vaccine

Straits Times 18 Feb 2026
The FDA has set a deadline of August to decide on whether to approve the vaccine ....
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Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance

Caledonian Record 18 Feb 2026
NEW YORK & MELBOURNE, Australia--(BUSINESS WIRE)--Feb 18, 2026-- ....
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USFDA issues Form 483 with 6 observations to Alkem subsidiary's Chakan plant

Business Line 16 Feb 2026
The company has achieved zero ...
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USFDA issues Form 483 with 4 observations to Piramal Pharma's Telangana unit

Business Line 14 Feb 2026
The US Food and Drug ...
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US FDA approves labeling changes to menopause hormone therapies

Hawaii Tribune-Herald 13 Feb 2026
(Reuters) — The U.S ... .
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US FDA declines to file application for Moderna’s new mRNA flu vaccine

Arab Times 11 Feb 2026
The US Food and Drug Administration is refusing to consider Moderna\u2019s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday ... The letter from FDA vaccine director Dr.
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US FDA declines Moderna flu vaccine review amid vaccine guidance rollback

Al Jazeera 11 Feb 2026
... were ready to review the application, including the head of the US agency’s vaccine office, David Kaslow, but were overridden by FDA commissioner Vinay Prasad, which the agency has disputed.
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US FDA says Novo's obesity pill TV ad is false or misleading

Business Line 10 Feb 2026
The health ​regulator said the television ...
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US FDA Reports Flag Rise In Injuries Linked To AI-Enabled Medical Devices: Report

News18 10 Feb 2026
At least 10 patients were injured between late 2021 and November 2025, according to FDA reports reviewed by Reuters ....
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Yang Sheng meets with associate commissioner for global policy and strategy of US FDA (National Medical Products Administration)

Public Technologies 03 Feb 2026
... Administration (NMPA) of China, met with a visiting delegation led by Mark Abdoo, associate commissioner for global regulatory operations and policy of the US Food and Drug Administration (FDA).
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Glaukos Announces US FDA Approval of NDA Supplement Allowing for Re-Administration of iDose® TR

Business Wire 28 Jan 2026
The FDA approval is in response to Glaukos’ 2025 NDA labeling supplement application, and re .

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