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Xbrane Plans Resubmission of Lucentis Biosimilar by June

[ Price : $8.95]

Xbrane Biopharma says it plans to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentechs Lucentis, which is i...

Lillys Oral Obesity Drug Foundayo Wins Approval

[ Price : $8.95]

Eli Lilly wins FDA approval for Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are over...

FDA-483 Not a Proxy for Overall Quality: Califf

[ Price : $8.95]

Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should c...

CGMP Deviations in Henan Lvyuan Inspection

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FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing prac...

Modernize DTC Ads with QR Code: WLF

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A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize t...

NIH-Funded Study to Assess GLP-1 Drugs in Alzheimers

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Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs co...

FDA Says Proposed Drug Import Guidance Unwarranted

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FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alternative funding programs.

Mitapivat Moving Toward Accelerated Approval in Sickle Cell: Agios

[ Price : $8.95]

Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission ...

FDA Warns of Serious Liver Risks Linked to Tavneos

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FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk o...

FDA Seeking Input on Expanding Digital Health Tech in Trials

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Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health...