Regulatory Event

NDA / BLA Submission

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

Recent events(6)

StrategyJuly 5, 2026

Aurobindo Pharma has submitted ANDA212597 for Pirfenidone, which has received Abbreviated Approval (AP) status.

StrategyJuly 1, 2026

Alembic's ANDA for Oseltamivir Phosphate has been granted Abbreviated Approval (AP) status by the FDA.

RegulatoryJune 28, 2026

Lannett Co Inc has received an approval status for their ANDA submission for Oxycodone and Acetaminophen.

StrategyJune 28, 2026

The FDA has approved the ANDA submission for ANEXSIA 5/325, containing acetaminophen and hydrocodone bitartrate.

StrategyJune 23, 2026

Aurobindo Pharma's ANDA for Risendronate Sodium has been granted Abbreviated Approval (AP) status by the FDA.

StrategyJune 6, 2026

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

NDA Submission

BTK inhibitor filing follows liver safety scrutiny across the class.

August 15, 2026 · Phase III

BLA Submission

Earlier-line bispecific filing intensifies crowded myeloma landscape.

July 1, 2026 · Phase III

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