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Keeping Track: Parsaclisib, Kymriah Applications Target Non-Hodgkin Lymphomas; AbbVie Gets New Use For Old Ophthalmic

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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With Vuity Approval, AbbVie Continues Stepping Into Eye Care

AbbVie had no presence in ophthalmic medicine other than a single indication for Humira before the Allergan merger, but now has a growing eye care portfolio, including early FDA approval of Vuity for presbyopia.

Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time

The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.

FDA Accepts ANI’s Refiled Cortophin Gel

ANI Pharmaceuticals has announced that the refiled sNDA for its Cortrophin Gel has been accepted by the FDA with a target action date of 29 October 2021. The company said that it was continuing to strengthen its rare disease business leadership team and overall organization to drive the Cortrophin Gel launch preparation.

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