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FDA Issues Promotional Guide for Biosimilars/Reference Biologics

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FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Prod...

FDA Says Looking at Safety of RSV Infant Therapies

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FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.

Envoy Medical QS Violations

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FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hea...

FDA Broadens Covid Vaccine Probe to Include Adult Deaths

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FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric d...

Experts Call for Overhaul of FDA Revolving Door Rules

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Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into p...

BioNTech, OncoC4 See Good Survival Data for Lung Cancer Drug

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BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for certain patients with ...

FDA Delays Decision on Agios Mitapivat sNDA for Thalassemia

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FDA delays its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both t...

Dyne Reports Strong Dystrophin Gains in Duchenne Study

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Dyne Therapeutics reports positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the invest...

House Dems Seek Answers on FDA Vaccine Memo

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Top House Democrats demand FDA provide documents and explanations after revelations that a senior FDA official circulated new vacc...

Petition Urges FDA to Overhaul Biosimilar Approval Rules

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A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval require...