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Make Better Use of 505(b)(2) Pathway: Column

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Two InnoDev Partners consultants urge industry to re-embrace the 505(b)(2) approval pathway in instances in which it can save drug...

China Surpasses U.S. in Novel Cancer Drug Approvals Since 2023: Analysis

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China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs begi...

Dyne Therapeutics BLA for Duchenne Muscular Dystrophy

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FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular...

Nevada Man Pleads Guilty to Importing and Selling Misbranded Drugs

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A Nevada businessman enters guilty plea to importing and distributing misbranded prescription erectile dysfunction drugs from Indi...

Study Finds Compounded GLP-1 Market Remains Strong Despite FDA Crackdown

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A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the F...

FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

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In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are inc...

Opinion Piece Praises Diamantas' Vision for FDA Modernization

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A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emp...

FDA Issues Early Alert on Baxter IV Administration Sets

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FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solut...

Fujifilm Diosynth Cited Over NC Plants Microbial Contamination Controls

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FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Resea...

Camurus NDA Resubmission for Acromegaly Therapy Accepted by FDA

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FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly.