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Draft Product-specific ANDA Guidances

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on ANDA bioequivalence ...

DTC Research Supports Disclosures on Endpoint Differentiation

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New FDA research on direct-to-consumer television ads finds that disclosures could help viewers in differentiating between progres...

Abiomed Recalls Impella 5.5. Blood Pump

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Abiomed recalls its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patients circul...

Zoll Settles Case Against China-made ECG Cables

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The Justice Department resolves civil claims requiring Zoll Medical to pay $400,000 for selling Chinese-made products to the feder...

Genmab BLA OKd for Large B-cell Lymphoma

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FDA grants Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with re...

Topical Gene Therapy for Wounds Approved

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FDA approves a Krystal Biotech BLA for Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy for treating wounds in pat...

Bionic Pancreas Cleared by FDA

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FDA clears a Beta Bionics 510(k) for its Bionic Pancreas for treating Type 1 diabetes in patients aged six years and older.

Revoke Approval for MSNs Generic Hetlioz: Vanda

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Vanda calls on FDA to revoke its approval of an MSN Pharmaceuticals ANDA for generic Hetlioz because it says the ANDA does not dem...

Nephron Pharmaceuticals Warehouse FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Nephron Pharmaceuticals warehouse in Murray, KY.

AbbVie Gets Rinvoq OK for Crohns

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FDA approves AbbVies Rinvoq (upadacitinib) for treating adults with moderately to severely active Crohns disease.