Fennec Pharmaceuticals Inc.
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Latest From Fennec Pharmaceuticals Inc.
After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.
Coming Up On US FDA’s User Fee Calendar: Zynteglo Approval Kicks Off Busy Season For Advanced Biologics, Pediatrics
At least 17 applications are pending with late August and September 2022 user fee goal dates, the Pink Sheet US FDA Performance Tracker shows.
Public Company Edition: MAIA launches a $10m initial public offering, the first in the US since May, but NewAmsterdam opts for the SPAC route to the stock market. Also, Legend raises $350m in a follow-on offering, Iveric obtains access to $250m in debt and Otonomy cuts costs after a Phase II failure.
US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.
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