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Regulatory Event

NDA / BLA Submission

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

Recent events: 20
Catalysts: 2
Companies: 12

Recent events(20)

StrategyAugust 14, 2026

Cipla's Ramipril ANDA Submission Receives AP Status from FDA

Cipla's ANDA for Ramipril (ANDA077004) has received Abbreviated Approval (AP) status from the FDA, with a standard review priority.

RegulatoryAugust 11, 2026

Delcath Systems' Hezato NDA Submission Receives Standard Review Status

Delcath Systems Inc. has submitted NDA201848 for Hezato, which contains melphalan hydrochloride, and is currently undergoing standard review by the FDA. This submission is categorized under the oncology therapeutic area, specifically targeting chemotherapy applications.

StrategyAugust 10, 2026

FDA grants AP status for Imatinib Mesylate ANDA submission by Hetero Labs

The FDA has granted approval status (AP) for the ANDA submission of Imatinib Mesylate by Hetero Labs, allowing the company to market a generic version of this tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia (CML).

RegulatoryAugust 6, 2026

FDA Accepts Doxycycline Hyclate ANDA Submission from Ajanta Pharma

Ajanta Pharma has submitted an Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate.

RegulatoryAugust 4, 2026

FDA grants AP status for Leuprolide Acetate ANDA215826 by Zydus Pharms

The FDA has granted approval status (AP) for the ANDA submission of Leuprolide Acetate by Zydus Pharms.

StrategyAugust 2, 2026

FDA Approval Update for Mycophenolate Mofetil by Hikma

Hikma has received an approval status for their ANDA submission for Mycophenolate Mofetil.

StrategyAugust 1, 2026

Aurobindo Pharma's Mycophenolate Sodium ANDA Submission Receives AP Status

Aurobindo Pharma Ltd. has received Abbreviated Approval (AP) for its ANDA218603 submission for Mycophenolate Sodium.

StrategyJuly 30, 2026

FDA Accepts Lenalidomide ANDA Submission from Torrent

The FDA has accepted the ANDA submission for Lenalidomide from Torrent Pharmaceuticals.

RegulatoryJuly 28, 2026

FDA Submission Status Update for Calcipotriene by Glenmark

The FDA has accepted the ANDA submission for Calcipotriene by Glenmark, indicating progress in the regulatory review process.

StrategyJuly 24, 2026

Teva's ANDA Submission for Canagliflozin Receives TA Status

Teva Pharmaceuticals has submitted an ANDA for Canagliflozin, currently under standard review with TA status.

RegulatoryJuly 21, 2026

FDA Grants Priority Review for ZAYNICH NDA Submission by Wockhardt Bio AG

The FDA has granted priority review for the NDA submission of ZAYNICH, containing cefepime hydrochloride and zidebactam.

RegulatoryJuly 19, 2026

FDA Acceptance of Linaclotide ANDA Submission by Actavis Labs

The FDA has accepted the ANDA submission for Linaclotide by Actavis Labs.

StrategyJuly 13, 2026

Heritage Pharma's Sertraline Hydrochloride ANDA Submission Receives AP Status

Heritage Pharma's ANDA for Sertraline Hydrochloride has been granted Abbreviated Approval (AP) status.

RegulatoryJuly 13, 2026

EUGIA PHARMA's Leuprolide Acetate ANDA Submission Receives AP Status

EUGIA PHARMA has received an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate.

StrategyJuly 5, 2026

Aurobindo Pharma's Pirfenidone ANDA Submission Receives AP Status

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

StrategyJuly 1, 2026

Alembic's Oseltamivir Phosphate ANDA Submission Receives AP Status

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

RegulatoryJune 28, 2026

FDA Approval Update for Oxycodone and Acetaminophen by Lannett Co Inc

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

StrategyJune 28, 2026

FDA Approves ANEXSIA 5/325 Submission by SPECGX LLC

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

StrategyJune 23, 2026

Aurobindo Pharma's Risendronate Sodium ANDA Submission Receives AP Status

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

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

Actavis Labs →

Ajanta Pharma →

Alembic Pharmaceuticals →

Aurobindo Pharma →

EUGIA PHARMA →

Heritage Pharma →

Hetero Labs →

Torrent Pharmaceuticals →

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