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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...

Amgen New Data Pushes Back Against Proposal to Withdraw Tavneos

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Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatmen...

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...

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.

FDA Should Ban DTC Drug Ads: Public Citizen

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Advocacy group Public Citizen files a petition urging FDA to ban prescription drug direct-to-consumer advertising.

FDA Accepts Revolution Medicines' NDA for Pancreatic Cancer Therapy

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FDA accepts for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with ...

2026 Warning Letter Trends Analyzed by Attorney

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Attorney Megan Robertsons analysis of 2026 FDA Warning Letters shows that CDER has been the most active Center, going after telehe...

4 Observations in Behring German Facility Inspection

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FDA releases the form FDA-483 issued following a 2026 inspection at the CSL Behring biological drug manufacturing facility in Marb...