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Epcoritamab Combo for Relapsed Follicular Lymphoma OKd

[ Price : $8.95]

FDA approves Genmabs Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refract...

Verdure Sciences Did Not Submit Trial IND: FDA

[ Price : $8.95]

FDA warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug M...

Redemplo OKd for Cutting High Triglycerides in Rare Disorder

[ Price : $8.95]

FDA approves an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adult...

Roches Giredestrant Promising Data in Early Breast Cancer

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Roche says its investigational selective estrogen receptor degrader giredestrant significantly improved invasive disease-free surv...

Significant CGMP Violations at World Perfumes

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FDA warns Opa-Locka, FL-based World Perfumes about CGMP violations in its production of finished drugs as a contract manufacturer.

FDA, Patent Office at Odds on Biosimilars: CBS News Report

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CBS News says the federal patent office is taking steps to slow challenges to innovator biologic drug patents by biosimilar drug m...

FDA Needs More Data on China Drug Production: Report

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A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect data from drug companies on where...

Petition Rejected on New Warnings for Surgical Mesh

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FDA denies a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mas...

Multiple Violations in DermaRite Inspection

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FDA warns North Bergen, NJ-based DermaRite Industries about CGMP, unapproved new drug, and misbranded drug violations in its produ...

FDA Generic User Fee Negotiations Offer Proposals

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FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Drug User Fee Amendments during a...