Hormonal Therapy — Therapeutic Area Intelligence | Humanexa Signals

RegulatoryAugust 17, 2026

Glenmark Pharmaceuticals receives FDA approval for Progesterone ANDA216363

Glenmark Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA216363) for Progesterone. This approval allows Glenmark to enter the hormonal therapy market, specifically targeting hormone replacement therapy and fertility treatment sectors.

RegulatoryAugust 9, 2026

FDA Grants Approval for Clomiphene Citrate by Ascent Pharms

The FDA has granted approval for Clomiphene Citrate under application ANDA220673 submitted by Ascent Pharms.

RegulatoryAugust 8, 2026

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

The FDA has accepted a supplemental NDA for YONSA (abiraterone acetate) submitted by Sun Pharma.

RegulatoryAugust 4, 2026

FDA grants approval status for Leuprolide Acetate ANDA215336

The FDA has granted an approval status (AP) for the ANDA215336 application for Leuprolide Acetate submitted by Amneal.

RegulatoryAugust 4, 2026

FDA Accepts Supplement for VANTAS (Histrelin Acetate) by Endo Operations

The FDA has accepted a supplemental NDA for VANTAS, which contains the active ingredient histrelin acetate.

RegulatoryAugust 4, 2026

FDA Accepts Supplement Application for ELIGARD Kit by TOLMAR

The FDA has accepted a supplemental application for the ELIGARD Kit, which contains leuprolide acetate.

RegulatoryAugust 4, 2026

FDA Approves Supplement for Leuprolide Acetate by PH Health

The FDA has approved a supplemental application for Leuprolide Acetate submitted by PH Health.

RegulatoryAugust 4, 2026

FDA grants approval status for Leuprolide Acetate ANDA217957

The FDA has granted an approval status (AP) for the ANDA217957 application for Leuprolide Acetate submitted by UBI.

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.

RegulatoryAugust 4, 2026

FDA Accepts Supplemental NDA for Eligard Kit by Tolmar

The FDA has accepted a supplemental NDA for the Eligard Kit, which contains leuprolide acetate.

RegulatoryAugust 4, 2026

FDA grants AP status for Leuprolide Acetate ANDA212963 by Eugia Pharma

The FDA has granted Abbreviated Approval (AP) status for Eugia Pharma's ANDA212963 for Leuprolide Acetate.

RegulatoryAugust 4, 2026

FDA Accepts Supplemental NDA for ZOLADEX by TERSERA

The FDA has accepted a supplemental NDA for ZOLADEX, an oncology drug containing goserelin acetate, submitted by TERSERA.

RegulatoryAugust 4, 2026

FDA Accepts Supplement for ZOLADEX (Goserelin) by TERSERA

The FDA has accepted a supplemental application for ZOLADEX (goserelin) submitted by TERSERA.

RegulatoryAugust 4, 2026

FDA Accepts Supplement for Lupron by AbbVie

The FDA has accepted a supplemental application for Lupron (leuprolide acetate) from AbbVie.

RegulatoryAugust 4, 2026

FDA Grants AP Status for Sandoz's Leuprolide Acetate Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status to Sandoz for a supplement of Leuprolide Acetate.

RegulatoryAugust 4, 2026

FDA Grants AP Status for Leuprolide Acetate ANDA213829

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate submitted by Somerset Therapies LLC.

RegulatoryAugust 4, 2026

FDA Accepts Supplemental NDA for Eligard Kit by Tolmar

The FDA has accepted a supplemental NDA for the Eligard Kit, which contains leuprolide acetate.

RegulatoryAugust 3, 2026

FDA Accepts Supplement for Leuprolide Acetate by Sun Pharma

The FDA has accepted a supplemental application for Leuprolide Acetate submitted by Sun Pharma.

RegulatoryAugust 3, 2026

FDA grants AP status for Leuprolide Acetate ANDA075471 by Meitheal

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate submitted by Meitheal.

RegulatoryAugust 3, 2026

FDA Accepts Supplemental Application for ZOLADEX by TERSERA

The FDA has accepted a supplemental application for ZOLADEX (Goserelin Acetate) submitted by TERSERA.

RegulatoryAugust 3, 2026

FDA Accepts Supplement Application for ELIGARD Kit by TOLMAR

The FDA has accepted a supplemental application for the ELIGARD Kit, containing leuprolide acetate.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for XTANDI (Enzalutamide)

The FDA has accepted a supplemental application for XTANDI (enzalutamide) submitted by Astellas.

RegulatoryJuly 28, 2026

FDA Accepts Supplement Application for Estradiol and Norethindrone Acetate

The FDA has accepted the supplemental application ANDA078324 for Estradiol and Norethindrone Acetate submitted by Breckenridge Pharmaceutical.

RegulatoryJuly 25, 2026

FDA Accepts Supplemental NDA for CAMCEVI ETM by ACCORD

The FDA has accepted the supplemental NDA for CAMCEVI ETM, containing leuprolide mesylate.

RegulatoryJuly 24, 2026

FDA Accepts Supplement for CAMCEVI ETM (Leuprolide Mesylate)

The FDA has accepted a supplemental application for CAMCEVI ETM, which contains leuprolide mesylate.

StrategyJuly 19, 2026

FDA Grants Approval for Clomiphene Citrate ANDA220673 by Ascent Pharms

The FDA has granted approval for ANDA220673, a generic version of Clomiphene Citrate, submitted by Ascent Pharms.

RegulatoryJuly 18, 2026

FDA Grants Approval for Enlicitide by Merck Sharp and Dohme

The FDA has granted approval for Enlicitide, an original application by Merck Sharp and Dohme.

RegulatoryJuly 18, 2026

FDA Accepts Supplement for ENDOMETRIN by Ferring

The FDA has accepted a supplemental application for ENDOMETRIN, a progesterone-based therapy.

RegulatoryJuly 16, 2026

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

The FDA has accepted a supplemental NDA for YONSA, which contains abiraterone acetate as the active ingredient.

ClinicalJuly 14, 2026

Sumitomo Pharma initiates observational study on ORGOVYX in prostate cancer patients

A multi-center, prospective, observational study is underway to assess the real-world safety and effectiveness of ORGOVYX in prostate cancer patients.

RegulatoryJuly 13, 2026

FDA Grants AP Status for Leuprolide Acetate ANDA215336 by Amneal

The FDA has granted Abbreviated Approval (AP) status for Amneal's ANDA215336 for Leuprolide Acetate.

RegulatoryJuly 13, 2026

FDA Grants AP Status for Leuprolide Acetate ANDA217957

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate submitted by UBI.

RegulatoryJuly 13, 2026

FDA Grants AP Status to Zydus' Leuprolide Acetate ANDA215826

The FDA has granted approval status (AP) for Zydus Pharmaceuticals' ANDA215826 for Leuprolide Acetate.

RegulatoryJuly 13, 2026

FDA Approves Supplemental Applications for ELIGARD Kit

The FDA has approved supplemental applications for the ELIGARD Kit, which contains leuprolide acetate.

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.

RegulatoryJuly 13, 2026

FDA Accepts Supplemental Application for ZOLADEX by TERSERA

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

RegulatoryJuly 13, 2026

FDA Accepts Supplemental Application for ZOLADEX by TERSERA

The FDA has accepted a supplemental application for ZOLADEX, an oncology drug containing goserelin acetate.

RegulatoryJuly 13, 2026

FDA Accepts Supplemental Application for Lupron by AbbVie

The FDA has accepted a supplemental application for Lupron, an injectable hormonal therapy.

StrategyJuly 13, 2026

FDA Grants Approval for Leuprolide Acetate ANDA213829

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 213829 for Leuprolide Acetate submitted by Somerset Therap LLC.

RegulatoryJuly 13, 2026

FDA Grants AP Status for Leuprolide Acetate ANDA078885 by Sun Pharma

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

RegulatoryJuly 13, 2026

FDA grants AP status for Leuprolide Acetate ANDA075471

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate submitted by Meitheal.

RegulatoryJuly 13, 2026

FDA Accepts Supplemental NDA for VANTAS by Endo Operations

The FDA has accepted a supplemental NDA for VANTAS, which contains the active ingredient histrelin acetate.

StrategyJuly 12, 2026

FDA Grants AP Status for Leuprolide Acetate ANDA217437

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Leuprolide Acetate submitted by PH Health.

StrategyJuly 5, 2026

FDA Approves ANDA078324 for Estradiol and Norethindrone Acetate

The FDA has granted approval for ANDA078324, a generic formulation of estradiol and norethindrone acetate.

RegulatoryJuly 3, 2026

FDA Approves Supplemental Applications for TRELSTAR

The FDA has approved supplemental applications for TRELSTAR, a triptorelin pamoate product.

RegulatoryJuly 1, 2026

FDA Accepts Supplemental NDA for TRELSTAR by Verity

The FDA has accepted a supplemental NDA for TRELSTAR, an injectable formulation of triptorelin pamoate.

RegulatoryJune 30, 2026

FDA Accepts Supplemental Application for ORSERDU (Elacestrant Hydrochloride)

The FDA has accepted a supplemental application for ORSERDU (elacestrant hydrochloride) from Stemline Therapeutics.

RegulatoryJune 22, 2026

FDA Grants Abiraterone Acetate ANDA208371 Approval Status

The FDA has granted application ANDA208371 for Abiraterone Acetate a status of Approved Pending (AP) under a supplemental submission.

Companies

Assets

Recent signals(48)

Glenmark Pharmaceuticals receives FDA approval for Progesterone ANDA216363

FDA Grants Approval for Clomiphene Citrate by Ascent Pharms

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

FDA grants approval status for Leuprolide Acetate ANDA215336

FDA Accepts Supplement for VANTAS (Histrelin Acetate) by Endo Operations

FDA Accepts Supplement Application for ELIGARD Kit by TOLMAR

FDA Approves Supplement for Leuprolide Acetate by PH Health

FDA grants approval status for Leuprolide Acetate ANDA217957

FDA grants AP status for Leuprolide Acetate ANDA215826 by Zydus Pharms

FDA Accepts Supplemental NDA for Eligard Kit by Tolmar

FDA grants AP status for Leuprolide Acetate ANDA212963 by Eugia Pharma

FDA Accepts Supplemental NDA for ZOLADEX by TERSERA

FDA Accepts Supplement for ZOLADEX (Goserelin) by TERSERA

FDA Accepts Supplement for Lupron by AbbVie

FDA Grants AP Status for Sandoz's Leuprolide Acetate Supplement

FDA Grants AP Status for Leuprolide Acetate ANDA213829

FDA Accepts Supplemental NDA for Eligard Kit by Tolmar

FDA Accepts Supplement for Leuprolide Acetate by Sun Pharma

FDA grants AP status for Leuprolide Acetate ANDA075471 by Meitheal

FDA Accepts Supplemental Application for ZOLADEX by TERSERA

FDA Accepts Supplement Application for ELIGARD Kit by TOLMAR

FDA Accepts Supplemental Application for XTANDI (Enzalutamide)

FDA Accepts Supplement Application for Estradiol and Norethindrone Acetate

FDA Accepts Supplemental NDA for CAMCEVI ETM by ACCORD

FDA Accepts Supplement for CAMCEVI ETM (Leuprolide Mesylate)

FDA Grants Approval for Clomiphene Citrate ANDA220673 by Ascent Pharms

FDA Grants Approval for Enlicitide by Merck Sharp and Dohme

FDA Accepts Supplement for ENDOMETRIN by Ferring

FDA Accepts Supplemental NDA for YONSA by Sun Pharma

Sumitomo Pharma initiates observational study on ORGOVYX in prostate cancer patients

FDA Grants AP Status for Leuprolide Acetate ANDA215336 by Amneal

FDA Grants AP Status for Leuprolide Acetate ANDA217957

FDA Grants AP Status to Zydus' Leuprolide Acetate ANDA215826

FDA Approves Supplemental Applications for ELIGARD Kit

EUGIA PHARMA's Leuprolide Acetate ANDA Submission Receives AP Status

FDA Accepts Supplemental Application for ZOLADEX by TERSERA

FDA Accepts Supplemental Application for ZOLADEX by TERSERA

FDA Accepts Supplemental Application for Lupron by AbbVie

FDA Grants Approval for Leuprolide Acetate ANDA213829

FDA Grants AP Status for Leuprolide Acetate ANDA078885 by Sun Pharma

FDA grants AP status for Leuprolide Acetate ANDA075471

FDA Accepts Supplemental NDA for VANTAS by Endo Operations

FDA Grants AP Status for Leuprolide Acetate ANDA217437

FDA Approves ANDA078324 for Estradiol and Norethindrone Acetate

FDA Approves Supplemental Applications for TRELSTAR

FDA Accepts Supplemental NDA for TRELSTAR by Verity

FDA Accepts Supplemental Application for ORSERDU (Elacestrant Hydrochloride)

FDA Grants Abiraterone Acetate ANDA208371 Approval Status

Upcoming catalysts

Indications

Get signals before the market moves