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Aimmune Therapeutics, Inc.

https://www.aimmune.com/

Latest From Aimmune Therapeutics, Inc.

PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals

Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.

User Fees Drug Review

Seres Banks Serious Cash To Drive Microbiome Therapy To Market

Seres and rival Ferring are both hoping to have the first-ever FDA-approved microbiome therapeutic but the US firm has secured a strong commercial partner in Nestlé's Aimmune pharma arm to drive SER-109 over the finishing line.

Infectious Diseases Deals

Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.

Approvals Review Pathway

DBV Soars As Path For Peanut Allergy Patch Approval Clears

The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.

Immune Disorders Drug Review
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Allergen Research Corporation (ARC)
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