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FDA Authorizes Moderna, Pfizer-BioNTech Boosters

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FDA authorizes Modernas and Pfizer-BioNTechs updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two mo...

FDA Loses California Stem Cell Treatment Case

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A California federal judge rejects FDA regulation of a stem cell clinic, saying it is engaged in the practice of medicine.

Novo Nordisk Pays $6.3 Million Over False Claims

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Novo Nordisk agrees to pay $6.3 million to resolve allegations that it violated the False Claims Act by selling its NovoFine needl...

FDA OKs Genzymes Xenpozyme for ASMD

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FDA approves Genzymes Xenpozyme to treat acid sphingomyelinase deficiency in children and adults.

Changes Sought in Drug Shortage Draft Guidance

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Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.

Baxter New Novum IQ Syringe Pump Cleared

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FDA clears a Baxter International 510(k) clearance of its new Novum IQ syringe infusion pump with Dose IQ Safety Software.

Amneal Files NDA for Parkinsons Drug

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Amneal Pharmaceuticals files an NDA for IPX203, a novel formulation of carbidopa/levodopa extended-release capsules for treating P...

Patient Groups Sue Over Drug Cost Rules

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Three patient advocacy groups sue HHS and the Centers for Medicare and Medicaid Services over their support for insurance companie...

Beam To Complete Clinical Hold Studies This Year

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Beam Therapeutics says it will complete studies requested by FDA as part of a clinical hold on a Beam-201 cancer treatment IND and...

Ubrelvy Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Allergans Ubrelvy (ubrogepa...