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Fennec Pharmaceuticals Expects To Receive Complete Response Letter From The FDA For Its New Drug Application For PEDMARK To Prevent Ototoxicity Associated With Cisplatin In Pediatric Patients With Localized, Non-Metastatic, Solid Tumors

Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of November 27, 2021 from the U.S. Food

FENC

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The Week Ahead In Biotech (Nov. 21-Nov. 27): Takeda, Aadi, Fennec FDA Decisions, Earnings In The Spotlight In Holiday-Shortened Week

Biotech stocks showed a lack of direction in the week ending Nov. 19 before finishing modestly higher. Stocks did not have much meaningful catalysts to react to amid the winding down of the reporting season and ahead of the holiday week.

AADI

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Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates

The loaded Prescription Drug User Fee Act (PDUFA) calendar for October produced mixed outcomes. PDUFA dates are key binary events for biotech stocks that can move the needle in a big way. These are the dates by which the Food and Drug Administration is required to announce its decision regarding approvability/non-approvability of drugs.

AADI