XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. The approved drugs contain the base form of semaglutide.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Manager of Regulatory Compliance.

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Delveinsight

JANUARY 5, 2021

The US FDA has accepted the initial Biologics License Application submission for the therapy with the target action date for an FDA decision is October 2021. FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device. SCONE Medical Solutions Inc.

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FDA Law Blog

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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The Pharma Data

JANUARY 9, 2021

. A follow-on procurement contract with HHS is expected for the delivery of raxibacumab, the Company’s Food and Drug Administration-approved anthrax monoclonal antibody therapeutic, to the Strategic National Stockpile (SNS). FOOTNOTES. (1)

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The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

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