Immunosuppressant

RegulatoryAugust 5, 2026

FDA Approves Supplemental Applications for CellCept (Mycophenolate Mofetil)

The FDA has approved supplemental applications for CellCept, indicating ongoing support for its use.

RegulatoryAugust 2, 2026

FDA Approval Process Update for Mycophenolate Sodium by Yichang Humanwell

The FDA has accepted the application ANDA214376 for Mycophenolate Sodium submitted by Yichang Humanwell, with a standard review priority.

RegulatoryAugust 2, 2026

FDA Approves Supplement for CellCept (Mycophenolate Mofetil) by Roche

The FDA has approved a supplemental application for CellCept, a drug containing mycophenolate mofetil hydrochloride, submitted by Roche.

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

The FDA has issued an approval status update for Hikma's ANDA065410 concerning Mycophenolate Mofetil.

StrategyAugust 2, 2026

Aurobindo Pharma's Mycophenolate Mofetil ANDA218227 Receives AP Status

Aurobindo Pharma's ANDA218227 for Mycophenolate Mofetil has received an Abbreviated Approval (AP) status from the FDA.

StrategyAugust 2, 2026

FDA Approval Update for Mycophenolate Mofetil by Hikma

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

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Sodium by RK Pharma

RK Pharma's application for Mycophenolate Sodium has received an approval status update from the FDA.

StrategyAugust 2, 2026

Aurobindo Pharma's Mycophenolate Mofetil ANDA217828 Receives AP Status

Aurobindo Pharma's application for Mycophenolate Mofetil (ANDA217828) has received Abbreviated Approval (AP) status from the FDA.

RegulatoryAugust 2, 2026

FDA Grants AP Status for Mycophenolate Mofetil ANDA214079 by WUXI

The FDA has granted an Abbreviated Approval (AP) for the ANDA214079 application for Mycophenolate Mofetil submitted by WUXI.

StrategyAugust 2, 2026

FDA Grants AP Status for Mycophenolate Sodium ANDA217031 by Biocon Pharma

The FDA has granted an Abbreviated Approval (AP) for the ANDA217031 application for Mycophenolate Sodium submitted by Biocon Pharma.

RegulatoryAugust 2, 2026

Aurobindo Pharma submits supplemental application for Mycophenolate Mofetil

Aurobindo Pharma has submitted a supplemental application for Mycophenolate Mofetil under ANDA217937.

StrategyAugust 1, 2026

Mylan Labs receives AP status for Mycophenolate Mofetil Hydrochloride ANDA203859

Mylan Labs Ltd. has received an Abbreviated Approval (AP) for their ANDA203859 application for Mycophenolate Mofetil Hydrochloride.

StrategyAugust 1, 2026

FDA Approves ANDA for Mycophenolate Mofetil by Hetero Labs

The FDA has approved ANDA208119 for Mycophenolate Mofetil submitted by Hetero Labs.

StrategyAugust 1, 2026

FDA Approves ANDA207022 for Mycophenolate Mofetil by Hetero Labs

The FDA has approved ANDA207022 for Mycophenolate Mofetil submitted by Hetero Labs.

RegulatoryAugust 1, 2026

FDA Approves Mycophenolate Mofetil Hydrochloride Supplement Application

The FDA has approved the supplemental application for Mycophenolate Mofetil Hydrochloride submitted by BPI Labs.

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.

RegulatoryJuly 24, 2026

FDA Approval Update for Azathioprine Supplement by Rising

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a supplement of Azathioprine by Rising.

StrategyJuly 22, 2026

FDA Grants Approval for Mycophenolate Mofetil ANDA218566 by Concord Biotech

The FDA has granted approval for the ANDA218566 application for Mycophenolate Mofetil submitted by Concord Biotech.

RegulatoryJuly 12, 2026

FDA Grants Approval for Mycophenolate Sodium by Yichang Humanwell

The FDA has granted approval for Mycophenolate Sodium under application ANDA214376 submitted by Yichang Humanwell.

RegulatoryJune 8, 2026

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

The FDA has an active application (ANDA212634) for Mycophenolate Mofetil submitted by Strides Pharma, currently under standard review.

Companies

Assets

Recent signals(20)

FDA Approves Supplemental Applications for CellCept (Mycophenolate Mofetil)

FDA Approval Process Update for Mycophenolate Sodium by Yichang Humanwell

FDA Approves Supplement for CellCept (Mycophenolate Mofetil) by Roche

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

Aurobindo Pharma's Mycophenolate Mofetil ANDA218227 Receives AP Status

FDA Approval Update for Mycophenolate Mofetil by Hikma

FDA Approval Status Update for Mycophenolate Sodium by RK Pharma

Aurobindo Pharma's Mycophenolate Mofetil ANDA217828 Receives AP Status

FDA Grants AP Status for Mycophenolate Mofetil ANDA214079 by WUXI

FDA Grants AP Status for Mycophenolate Sodium ANDA217031 by Biocon Pharma

Aurobindo Pharma submits supplemental application for Mycophenolate Mofetil

Mylan Labs receives AP status for Mycophenolate Mofetil Hydrochloride ANDA203859

FDA Approves ANDA for Mycophenolate Mofetil by Hetero Labs

FDA Approves ANDA207022 for Mycophenolate Mofetil by Hetero Labs

FDA Approves Mycophenolate Mofetil Hydrochloride Supplement Application

Aurobindo Pharma's Mycophenolate Sodium ANDA Submission Receives AP Status

FDA Approval Update for Azathioprine Supplement by Rising

FDA Grants Approval for Mycophenolate Mofetil ANDA218566 by Concord Biotech

FDA Grants Approval for Mycophenolate Sodium by Yichang Humanwell

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

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