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  1. Home
  2. /Regulatory
  3. /Nda Bla Submission

Regulatory Event

NDA / BLA Submission

New Drug Application and Biologics License Application filings that initiate formal regulatory review.

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Catalysts
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Companies
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Recent events(1)

StrategyJune 6, 2026

Aurobindo Pharma's Lamotrigine ANDA Submission Receives AP Status

Aurobindo Pharma's ANDA078956 for Lamotrigine has received an Abbreviated Approval (AP) status from the FDA.

Historical activity(2)

NDA Submission

Sanofi — Tolebrutinib

BTK inhibitor filing follows liver safety scrutiny across the class.

August 15, 2026 · Phase III

BLA Submission

Pfizer — Elranatamab

Earlier-line bispecific filing intensifies crowded myeloma landscape.

July 1, 2026 · Phase III

Related companies

Aurobindo Pharma →
Pfizer →
Sanofi →

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