Akebia Therapeutics scored a long-awaited win Tuesday when it announced the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data.
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While the FTC’s proposed rulemaking would affect every industry, the impact it could have on biopharma and biotech companies is unique due to the technologically advanced and secretive nature of the research and information gathered and its value to other companies.
To further support pharma manufacturing partners and ensure launch delays are avoided, the company has deepened its expertise with REMS Strategy and Project Management solutions.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
