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FDA Rejects Apiject's NDA for Glycopyrrolate Combination Product

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FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate soluti...

FDA Early Alert Over Boston Scientific Transcarotid Catheter Systems

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FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transc...

FDA Advisers Back Expanded Access to Several Compounded Peptides

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An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the ag...

FDA cites Bausch + Lomb Manufacturing Facility

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FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility i...

FDA: PDUFA 7 CMC Commitments Complete

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FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...

Efforts Needed to Improve Health Outcomes, Califf Says

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Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to imp...

HELP Committee Advances Biosimilar Bill

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The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by...

FDA Cites SGS France Life Sciences Over Bioanalytical Method Validation

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A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involv...

J&J Reports Positive Data From Multiple Myeloma Study

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Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecva...

Lillys Retatrutide Hits Endpoint in 2 Trials

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Lilly says its triple hormone receptor agonist retatrutide met the primary weight loss endpoint in two Phase 3 trials.