JAK Inhibitor — Therapeutic Area Intelligence | Humanexa Signals

RegulatoryAugust 5, 2026

FDA Submission Update for Ruxolitinib by Apotex

Apotex has submitted New Drug Application (NDA) for Ruxolitinib under application number NDA219660.

RegulatoryAugust 3, 2026

FDA Approves JAKAFI XR (Ruxolitinib Phosphate) Submission by Incyte

The FDA has approved the New Drug Application (NDA) for JAKAFI XR, a formulation of ruxolitinib phosphate, submitted by Incyte Corporation.

RegulatoryAugust 1, 2026

FDA Submission for Ruxolitinib by Apotex Receives Standard Review Status

Apotex has submitted New Drug Application for Ruxolitinib under NDA219660, which is currently under standard review.

ClinicalJuly 27, 2026

Novartis initiates long-term safety study for ruxolitinib and panobinostat combination

Novartis is conducting a long-term safety study for patients previously treated with ruxolitinib or its combination with panobinostat.

RegulatoryJuly 26, 2026

Post-marketing Surveillance for Xeljanz XR to Evaluate Safety in Rheumatoid Arthritis and Related Conditions

A post-marketing surveillance study for Xeljanz XR will assess its safety and effectiveness in routine clinical practice in Korea.

RegulatoryJuly 25, 2026

FDA Accepts Supplement for RINVOQ (Upadacitinib) by AbbVie

The FDA has accepted a supplemental application for RINVOQ (upadacitinib), indicating ongoing development and potential label expansion.

RegulatoryJuly 24, 2026

FDA Accepts Supplemental NDA for VONJO (Pacritinib Citrate)

The FDA has accepted a supplemental NDA for VONJO, JAK inhibitor, indicating progress in its regulatory pathway.

RegulatoryJuly 24, 2026

FDA Accepts Supplement for JAKAFI (Ruxolitinib Phosphate) by Incyte

The FDA has accepted a supplemental application for JAKAFI, JAK inhibitor developed by Incyte.

CompetitiveJuly 23, 2026

Aurobindo Pharma's ANDA for Tofacitinib Citrate Receives AP Status

Aurobindo Pharma's ANDA for Tofacitinib Citrate has received an Abbreviated Approval (AP) status from the FDA.

StrategyJuly 23, 2026

FDA Approves ANDA for Tofacitinib Citrate by Sun Pharma

The FDA has granted approval for ANDA218407, a generic version of Tofacitinib Citrate submitted by Sun Pharma.

StrategyJuly 23, 2026

Apotex submits ANDA for Tofacitinib Citrate, FDA review ongoing

Apotex has submitted an Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate, currently under FDA review.

StrategyJuly 23, 2026

FDA Approves Breckenridge's Tofacitinib Citrate Application

The FDA has approved Breckenridge's application for Tofacitinib Citrate under ANDA209633.

RegulatoryJuly 22, 2026

FDA Grants Approval for Tofacitinib Citrate (ANDA217298)

The FDA has granted approval for Tofacitinib Citrate under ANDA217298, submitted by MSN.

RegulatoryJuly 22, 2026

FDA Approval Letter for Tofacitinib Citrate by Micro Labs

The FDA has issued an approval letter for ANDA209738 for Tofacitinib Citrate submitted by Micro Labs.

RegulatoryJuly 22, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA220137

The FDA has granted approval for the ANDA of Tofacitinib Citrate submitted by Somerset Therap LLC.

RegulatoryJuly 12, 2026

FDA Approves JAKAFI XR for Incyte Corp.

The FDA has approved JAKAFI XR, a formulation of ruxolitinib phosphate, for use.

RegulatoryJuly 10, 2026

FDA Approves Supplemental Application for RINVOQ LQ by AbbVie

The FDA has approved a supplemental application for RINVOQ LQ (upadacitinib) submitted by AbbVie.

RegulatoryJuly 9, 2026

FDA Accepts Supplemental Application for XELJANZ (Tofacitinib Citrate)

The FDA has accepted a supplemental application for XELJANZ, indicating ongoing development and potential label expansion.

RegulatoryJuly 9, 2026

FDA Accepts Supplemental NDA for CIBINQO (Abrocitinib) by Pfizer

The FDA has accepted a supplemental NDA for CIBINQO (abrocitinib), indicating progress in its regulatory review.

RegulatoryJuly 9, 2026

FDA Approves Supplemental Application for XELJANZ XR by Pfizer

The FDA has approved a supplemental application for XELJANZ XR, JAK inhibitor developed by Pfizer.

RegulatoryJuly 9, 2026

LEO Pharma's Delgocitinib NDA219155 Receives AP Status from FDA

LEO Pharma's supplemental NDA for Delgocitinib has been granted an Approval Pending (AP) status by the FDA.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for OLUMIANT (Baricitinib) by Eli Lilly

The FDA has accepted a supplemental application for OLUMIANT (Baricitinib) from Eli Lilly.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for OPZELURA (Ruxolitinib Phosphate) by Incyte

The FDA has accepted a supplemental application for OPZELURA, an indication for Ruxolitinib Phosphate.

RegulatoryJuly 8, 2026

FDA Approves Supplemental NDA for Pfizer's Ritlecitinib Tosylate (Litfulo)

The FDA has approved a supplemental NDA for Litfulo (ritlecitinib tosylate) submitted by Pfizer.

RegulatoryJuly 8, 2026

FDA Grants Abbreviated Approval for Tofacitinib Citrate by Sciegen Pharmaceuticals

The FDA has granted abbreviated approval for Tofacitinib Citrate under application ANDA220972 submitted by Sciegen Pharmaceuticals.

ClinicalJuly 8, 2026

Eisai Initiates Post-Marketing Study of Jyseleca in Korea to Assess Safety and Efficacy

Eisai Korea Inc. is conducting a post-marketing study to evaluate the safety and efficacy of Jyseleca (Filgotinib Maleate) in Korean participants.

StrategyJune 30, 2026

FDA Accepts ANDA for Tofacitinib Citrate by Aurobindo Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate submitted by Aurobindo Pharma.

RegulatoryJune 22, 2026

FDA Acceptance of Tofacitinib Citrate Application by Zydus Pharms

The FDA has accepted the application for Tofacitinib Citrate submitted by Zydus Pharms.

StrategyJune 22, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA219395

The FDA has granted approval for ANDA219395, a generic formulation of Tofacitinib Citrate by SPECGX LLC.

StrategyJune 22, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA219530 by Macleods Pharmaceuticals

The FDA has granted approval for ANDA219530, a generic version of Tofacitinib Citrate, submitted by Macleods Pharmaceuticals.

CompetitiveJune 22, 2026

Apotex submits ANDA for Tofacitinib Citrate

Apotex has submitted an Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate, currently under standard review.

StrategyJune 22, 2026

FDA Approves ANDA for Tofacitinib Citrate by MSN

The FDA has approved the ANDA217299 application for Tofacitinib Citrate submitted by MSN.

RegulatoryJune 21, 2026

FDA Accepts ANDA for Tofacitinib Citrate by YAOPHARMA

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Tofacitinib Citrate submitted by YAOPHARMA.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA219830 by Orient Pharma

The FDA has granted approval for the ANDA219830 application for Tofacitinib Citrate submitted by Orient Pharma.

StrategyJune 21, 2026

FDA Approves ANDA for Tofacitinib Citrate by Auson

The FDA has approved the ANDA219370 for Tofacitinib Citrate submitted by Auson.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218821 by Concord Biotech

The FDA has granted approval for ANDA218821, a generic version of tofacitinib citrate submitted by Concord Biotech.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218900 by Saptalis Pharmaceuticals

The FDA has granted approval for ANDA218900, a generic version of Tofacitinib Citrate, submitted by Saptalis Pharmaceuticals.

CompetitiveJune 18, 2026

Apotex Inc. Submits ANDA for Ruxolitinib

Apotex Inc. has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating a move to enter the market.

Companies

Assets

Recent signals(38)

FDA Submission Update for Ruxolitinib by Apotex

FDA Approves JAKAFI XR (Ruxolitinib Phosphate) Submission by Incyte

FDA Submission for Ruxolitinib by Apotex Receives Standard Review Status

Novartis initiates long-term safety study for ruxolitinib and panobinostat combination

Post-marketing Surveillance for Xeljanz XR to Evaluate Safety in Rheumatoid Arthritis and Related Conditions

FDA Accepts Supplement for RINVOQ (Upadacitinib) by AbbVie

FDA Accepts Supplemental NDA for VONJO (Pacritinib Citrate)

FDA Accepts Supplement for JAKAFI (Ruxolitinib Phosphate) by Incyte

Aurobindo Pharma's ANDA for Tofacitinib Citrate Receives AP Status

FDA Approves ANDA for Tofacitinib Citrate by Sun Pharma

Apotex submits ANDA for Tofacitinib Citrate, FDA review ongoing

FDA Approves Breckenridge's Tofacitinib Citrate Application

FDA Grants Approval for Tofacitinib Citrate (ANDA217298)

FDA Approval Letter for Tofacitinib Citrate by Micro Labs

FDA Grants Approval for Tofacitinib Citrate ANDA220137

FDA Approves JAKAFI XR for Incyte Corp.

FDA Approves Supplemental Application for RINVOQ LQ by AbbVie

FDA Accepts Supplemental Application for XELJANZ (Tofacitinib Citrate)

FDA Accepts Supplemental NDA for CIBINQO (Abrocitinib) by Pfizer

FDA Approves Supplemental Application for XELJANZ XR by Pfizer

LEO Pharma's Delgocitinib NDA219155 Receives AP Status from FDA

FDA Accepts Supplement for OLUMIANT (Baricitinib) by Eli Lilly

FDA Accepts Supplement for OPZELURA (Ruxolitinib Phosphate) by Incyte

FDA Approves Supplemental NDA for Pfizer's Ritlecitinib Tosylate (Litfulo)

FDA Grants Abbreviated Approval for Tofacitinib Citrate by Sciegen Pharmaceuticals

Eisai Initiates Post-Marketing Study of Jyseleca in Korea to Assess Safety and Efficacy

FDA Accepts ANDA for Tofacitinib Citrate by Aurobindo Pharma

FDA Acceptance of Tofacitinib Citrate Application by Zydus Pharms

FDA Grants Approval for Tofacitinib Citrate ANDA219395

FDA Grants Approval for Tofacitinib Citrate ANDA219530 by Macleods Pharmaceuticals

Apotex submits ANDA for Tofacitinib Citrate

FDA Approves ANDA for Tofacitinib Citrate by MSN

FDA Accepts ANDA for Tofacitinib Citrate by YAOPHARMA

FDA Grants Approval for Tofacitinib Citrate ANDA219830 by Orient Pharma

FDA Approves ANDA for Tofacitinib Citrate by Auson

FDA Grants Approval for Tofacitinib Citrate ANDA218821 by Concord Biotech

FDA Grants Approval for Tofacitinib Citrate ANDA218900 by Saptalis Pharmaceuticals

Apotex Inc. Submits ANDA for Ruxolitinib

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