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FDA Clears Medians AI Lung Cancer Screener

[ Price : $8.95]

FDA clears a Median Technologies 510(k) for eyonis LCS, the first artificial intelligencebased device cleared for both detection a...

Partial Agreement in PDUFA Talks on Regulatory Science

[ Price : $8.95]

FDA drug regulators and pharmaceutical industry representatives reach a partial agreement on drug development tools, including bio...

BIO Urges Broader Guidance on Monoclonal Antibody Safety Testing

[ Price : $8.95]

The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streaml...

Hims & Hers Scraps Compounded GLP-1 Pill Program

[ Price : $8.95]

Faced with increasing FDA scrutiny and litigation threats from Novo Nordisk, Hims & Hers abruptly shelves its GLP 1 weight loss pi...

FDA Removes Use Limitation for Yescarta in Rare Lymphoma

[ Price : $8.95]

FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation ...

Makary Warns Illegal Copycat Drugs Will Face Swift Enforcement

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FDA pledges to move quickly against companies that mass-market illegal copycat drugs by portraying them as equivalent to agency-ap...

Breakthrough Status for Sonorous BosSTENT for Pulsatile Tinnitus

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FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat de...

Trust in FDA and CDC Remains Low After Vaccine Changes

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A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to t...

FDA Flags Manufacturing/Quality Lapses at Ipcas India API Plant

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FDA cites Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the companys active ph...

Congress Clarifies Orphan Drug Exclusivity & Generic Transparency

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A new spending package enacted this week includes two long-sought policy changes for FDA clarifying the scope of orphan drug excl...