Chemotherapy — Therapeutic Area Intelligence | Humanexa Signals

StrategyAugust 5, 2026

FDA Approval Process Update for Capecitabine ANDA204345 by Dr. Reddy's

Reddy's has submitted an Abbreviated New Drug Application (ANDA) for Capecitabine, currently under standard review.

RegulatoryAugust 5, 2026

FDA Grants Approval Status for Capecitabine ANDA204741 by Amneal Pharmaceuticals

The FDA has granted an approval status of 'AP' for Amneal Pharmaceuticals' ANDA204741 for Capecitabine.

RegulatoryAugust 3, 2026

FDA Accepts NDA for Trabectedin by Apotex

The FDA has accepted the New Drug Application (NDA) for Trabectedin submitted by Apotex.

RegulatoryAugust 2, 2026

FDA Approves Methotrexate Sodium Application ANDA219865

The FDA has approved the application ANDA219865 for Methotrexate Sodium submitted by Hetero Labs Ltd.

RegulatoryAugust 1, 2026

FDA Approves Supplement for Cytarabine by Hospira

The FDA has approved a supplemental application for Cytarabine submitted by Hospira.

RegulatoryJuly 29, 2026

FDA Grants Original Approval for Fludarabine Phosphate by Hisun Pharm

The FDA has granted original approval for Fludarabine Phosphate under application ANDA220196 submitted by Hisun Pharm Hangzhou.

ClinicalJuly 28, 2026

Phase II Trial of Paclitaxel and Cixutumumab in Metastatic Esophageal Cancer

A randomized phase II trial is evaluating the efficacy of paclitaxel with or without cixutumumab in metastatic esophageal cancer.

ClinicalJuly 28, 2026

Phase II Trial of Paclitaxel and Cixutumumab in Metastatic Esophageal Cancer

A randomized phase II trial is evaluating the efficacy of paclitaxel with or without cixutumumab in metastatic esophageal cancer.

RegulatoryJuly 27, 2026

FDA Grants Approval for Methotrexate Sodium by Alembic

The FDA has granted approval for Methotrexate Sodium under application ANDA220225 submitted by Alembic.

ClinicalJuly 26, 2026

Lenalidomide being studied for treatment of adult histiocyte disorders

A clinical trial is investigating Lenalidomide for treating Langerhans cell histiocytosis, Erdheim-Chester disease, and histiocytic sarcoma.

RegulatoryJuly 25, 2026

Actavis Inc. Submits Supplement for Gemcitabine Hydrochloride (ANDA204549)

Actavis Inc. has submitted a supplemental application for Gemcitabine Hydrochloride under ANDA204549, which is currently under standard review.

RegulatoryJuly 25, 2026

Sunny Pharmtech Issues Recall of Cyclophosphamide Injection Due to Contamination

Sunny Pharmtech is recalling Cyclophosphamide for Injection due to contamination with particulate matter identified as steel.

RegulatoryJuly 22, 2026

FDA Grants AP Status for Zydus' Arsenic Trioxide ANDA206228

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' Abbreviated New Drug Application for Arsenic Trioxide.

RegulatoryJuly 22, 2026

FDA Accepts ANDA for Eribulin Mesylate by NATCO

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Eribulin Mesylate submitted by NATCO.

RegulatoryJuly 21, 2026

FDA Approves Supplement for HEPZATO by Delcath Systems

The FDA has approved a supplemental application for HEPZATO, containing melphalan hydrochloride.

RegulatoryJuly 21, 2026

FDA Accepts Supplemental Application for XATMEP (Methotrexate Sodium)

The FDA has accepted a supplemental application for XATMEP, a formulation of methotrexate sodium.

RegulatoryJuly 21, 2026

Alembic's Methotrexate Sodium ANDA217552 Receives AP Status from FDA

Alembic's application for Methotrexate Sodium has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Methotrexate Sodium ANDA213343

The FDA has granted Abbreviated Approval (AP) status for ANDA213343, a methotrexate sodium supplement submitted by Accord Healthcare.

RegulatoryJuly 20, 2026

FDA Approves Supplemental Application for Methotrexate Sodium by Hikma

The FDA has approved a supplemental application for Methotrexate Sodium submitted by Hikma.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Methotrexate Sodium ANDA213362

The FDA has granted approval status (AP) for the ANDA213362 application for Methotrexate Sodium submitted by Daito.

RegulatoryJuly 20, 2026

FDA Approval Update for TREXALL (Methotrexate Sodium) by Barr

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for TREXALL, a methotrexate sodium product by Barr.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental Application for Methotrexate Sodium by Strides Pharma

The FDA has accepted a supplemental application for Methotrexate Sodium submitted by Strides Pharma.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Zydus' Methotrexate Sodium Supplement

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' supplemental application for Methotrexate Sodium.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Methotrexate Sodium ANDA216453

The FDA has granted approval status (AP) for the ANDA216453 application for Methotrexate Sodium submitted by Elite Labs Inc.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Methotrexate Sodium ANDA081099 by Barr

The FDA has granted Abbreviated Approval (AP) status for Barr's ANDA081099 for Methotrexate Sodium.

RegulatoryJuly 20, 2026

Amneal Pharmaceuticals Receives AP Status for Methotrexate Sodium ANDA210040

Amneal Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Methotrexate Sodium.

StrategyJuly 20, 2026

Mylan's Methotrexate Sodium ANDA081235 Receives Abbreviated Approval

Mylan's ANDA081235 for Methotrexate Sodium has received an abbreviated approval from the FDA.

RegulatoryJuly 20, 2026

FDA Grants AP Status for Methotrexate Sodium ANDA201749 by Sun Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Methotrexate Sodium submitted by Sun Pharma.

RegulatoryJuly 20, 2026

FDA Accepts Supplemental NDA for JYLAMVO by SHORLA

The FDA has accepted a supplemental NDA for JYLAMVO, which contains methotrexate as an active ingredient.

RegulatoryJuly 20, 2026

Eugia Pharma's Methotrexate Sodium ANDA210454 Receives AP Status

Eugia Pharma's application for Methotrexate Sodium (ANDA210454) has received an Abbreviated Approval (AP) status from the FDA.

StrategyJuly 13, 2026

FDA Grants AP Status for Dr. Reddy's Capecitabine ANDA204345

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Dr. Reddy's Capecitabine.

CompetitiveJuly 13, 2026

Amneal Pharmaceuticals submits supplemental ANDA for Capecitabine

Amneal Pharmaceuticals has submitted a supplemental abbreviated new drug application (ANDA) for Capecitabine.

RegulatoryJuly 12, 2026

FDA Accepts NDA for Trabectedin by Apotex

The FDA has accepted the New Drug Application (NDA) for Trabectedin submitted by Apotex.

RegulatoryJuly 12, 2026

FDA Accepts NDA for Trabectedin by Apotex

The FDA has accepted the New Drug Application (NDA) for Trabectedin submitted by Apotex.

StrategyJuly 11, 2026

FDA Grants Approval for Methotrexate Sodium ANDA219865 by Hetero Labs

The FDA has granted approval for the ANDA219865 application for Methotrexate Sodium submitted by Hetero Labs.

RegulatoryJuly 11, 2026

FDA Submission for Cyclophosphamide by Hetero Labs Limited

Hetero Labs Limited has submitted an original application for Cyclophosphamide under ANDA219271 with standard review priority.

StrategyJuly 9, 2026

FDA Accepts ANDA for Capecitabine by Reliance Life

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Capecitabine submitted by Reliance Life.

StrategyJuly 9, 2026

FDA Grants AP Status for Capecitabine ANDA210203 by Hetero Labs

Hetero Labs has received an Abbreviated Approval (AP) for their ANDA210203 application for Capecitabine.

RegulatoryJuly 8, 2026

FDA Approves Supplemental NDA for HEPZATO by Delcath Systems

The FDA has approved a supplemental NDA for HEPZATO, which contains melphalan hydrochloride.

RegulatoryJuly 4, 2026

Alembic's Methotrexate Sodium ANDA220225 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Methotrexate Sodium submitted by Alembic.

ClinicalJuly 3, 2026

Modeling Hyperthermia-Enhanced Delivery of Doxorubicin in Solid Tumors

Mathematical modeling shows that timing hyperthermia with peak plasma TSL-DOX levels can double intracellular doxorubicin concentration.

RegulatoryJune 24, 2026

Accord Healthcare Recalls Carmustine Due to Out of Specification Test Result

Accord Healthcare is recalling a batch of Carmustine 100 mg due to an out of specification test result.

RegulatoryJune 21, 2026

FDA Approves Supplemental Application for Capecitabine by Accord Healthcare

The FDA has approved a supplemental application for Capecitabine submitted by Accord Healthcare.

RegulatoryJune 21, 2026

FDA Grants AP Status for Azacitidine ANDA204949 by Pharmobedient

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Azacitidine submitted by Pharmobedient.

RegulatoryJune 21, 2026

FDA Grants AP Status for Azacitidine ANDA204949 by Pharmobedient

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Azacitidine submitted by Pharmobedient.

Companies

Assets

Recent signals(45)

FDA Approval Process Update for Capecitabine ANDA204345 by Dr. Reddy's

FDA Grants Approval Status for Capecitabine ANDA204741 by Amneal Pharmaceuticals

FDA Accepts NDA for Trabectedin by Apotex

FDA Approves Methotrexate Sodium Application ANDA219865

FDA Approves Supplement for Cytarabine by Hospira

FDA Grants Original Approval for Fludarabine Phosphate by Hisun Pharm

Phase II Trial of Paclitaxel and Cixutumumab in Metastatic Esophageal Cancer

Phase II Trial of Paclitaxel and Cixutumumab in Metastatic Esophageal Cancer

FDA Grants Approval for Methotrexate Sodium by Alembic

Lenalidomide being studied for treatment of adult histiocyte disorders

Actavis Inc. Submits Supplement for Gemcitabine Hydrochloride (ANDA204549)

Sunny Pharmtech Issues Recall of Cyclophosphamide Injection Due to Contamination

FDA Grants AP Status for Zydus' Arsenic Trioxide ANDA206228

FDA Accepts ANDA for Eribulin Mesylate by NATCO

FDA Approves Supplement for HEPZATO by Delcath Systems

FDA Accepts Supplemental Application for XATMEP (Methotrexate Sodium)

Alembic's Methotrexate Sodium ANDA217552 Receives AP Status from FDA

FDA Grants AP Status for Methotrexate Sodium ANDA213343

FDA Approves Supplemental Application for Methotrexate Sodium by Hikma

FDA Grants AP Status for Methotrexate Sodium ANDA213362

FDA Approval Update for TREXALL (Methotrexate Sodium) by Barr

FDA Accepts Supplemental Application for Methotrexate Sodium by Strides Pharma

FDA Grants AP Status for Zydus' Methotrexate Sodium Supplement

FDA Grants AP Status for Methotrexate Sodium ANDA216453

FDA Grants AP Status for Methotrexate Sodium ANDA081099 by Barr

Amneal Pharmaceuticals Receives AP Status for Methotrexate Sodium ANDA210040

Mylan's Methotrexate Sodium ANDA081235 Receives Abbreviated Approval

FDA Grants AP Status for Methotrexate Sodium ANDA201749 by Sun Pharma

FDA Accepts Supplemental NDA for JYLAMVO by SHORLA

Eugia Pharma's Methotrexate Sodium ANDA210454 Receives AP Status

FDA Grants AP Status for Dr. Reddy's Capecitabine ANDA204345

Amneal Pharmaceuticals submits supplemental ANDA for Capecitabine

FDA Accepts NDA for Trabectedin by Apotex

FDA Accepts NDA for Trabectedin by Apotex

FDA Grants Approval for Methotrexate Sodium ANDA219865 by Hetero Labs

FDA Submission for Cyclophosphamide by Hetero Labs Limited

FDA Accepts ANDA for Capecitabine by Reliance Life

FDA Grants AP Status for Capecitabine ANDA210203 by Hetero Labs

FDA Approves Supplemental NDA for HEPZATO by Delcath Systems

Alembic's Methotrexate Sodium ANDA220225 Receives AP Status from FDA

Modeling Hyperthermia-Enhanced Delivery of Doxorubicin in Solid Tumors

Accord Healthcare Recalls Carmustine Due to Out of Specification Test Result

FDA Approves Supplemental Application for Capecitabine by Accord Healthcare

FDA Grants AP Status for Azacitidine ANDA204949 by Pharmobedient

FDA Grants AP Status for Azacitidine ANDA204949 by Pharmobedient

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