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Cybrexa Therapeutics to Begin Cancer Trial of CBX-12

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FDA gives Cybrexa Therapeutics the green light to begin a clinical trial for solid tumor therapy CBX-12 (alphalex-exatecan).

Meeting on Device Patient-generated Data

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FDA announces a 5/4 virtual public meeting entitled Patient-Generated Health Data Throughout the Total Product Life Cycle of Medic...

BMS NDA for Inherited Heart Condition

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FDA accepts a Bristol Myers Squibb NDA for mavacamten, an investigational allosteric modulator of cardiac myosin for treating pati...

CBER Untitled Letter on Cancer Immunotherapy

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CBERs Office of Compliance and Biologics Quality sends Reno Integrative Medical Center an untitled letter after reviewing the inst...

Safety Alert on BD ChloraPrep Applicators

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An FDA safety alert advises that health care professionals not use Becton, Dickinsons ChloraPrep 3 mL applicators due to microbial...

SUNSET Rule Effective Date Postponed

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Federal Register notice: HHS postpones, pending judicial review, the effective date of a final rule entitled Securing Updated and ...

Janssens Ponvory Approved for Multiple Sclerosis

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FDA approves a Janssen NDA for Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor modulator for tre...

Kiniksa Pharmas Arcalyst OKd for Pericarditis

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FDA approves a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis in adults and child...

Comments on FDA Dry Eye Drug Development Guidance

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AbbVie and Allergan comment on a draft FDA guidance on developing drugs for dry eye.

Lilly Covid Drug Pulled in 3 States Due to Variant

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FDA acting commissioner Janet Woodcock says the government has stopped distributing a Lilly monoclonal antibody in three western s...