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NEWS #PharmaBuzz
22 Aug 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/amag-loses-insurance-claim-tied-manufacturing-snafu-pfizers-previously-trouble-mcpherson
21 Aug 2021
// N. H. Dunn FIERCEPHARMA
https://www.fiercepharma.com/pharma/covis-granted-fda-hearing-latest-twist-over-controversial-premature-birth-med-makena
30 Mar 2021
// Kari Oakes RAPS
https://www.raps.org/news-and-articles/news-articles/2021/3/fda-unmoved-by-new-meta-analysis-still-recommends
14 Dec 2020
// GLOBENEWSWIRE
https://www.globenewswire.com/fr/news-release/2020/12/14/2144543/0/en/AMAG-Pharmaceuticals-Files-Submission-in-Response-To-the-Food-And-Drug-Administration-s-Notice-of-Opportunity-for-a-Hearing-and-Proposal-To-Withdraw-Approval-of-Makena-hydroxyproge.html
16 Nov 2020
// BIOSPACE
https://www.biospace.com/article/releases/covis-group-completes-acquisition-of-amag-pharmaceuticals/?s=79
16 Nov 2020
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/covis-group-completes-acquisition-of-amag-pharmaceuticals-301173667.html
Drugs in Development
Details:
Makena (hydroxyprogesterone caproate) is a synthetic progestin. The drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. It has been withdrawn and cannot lawfully be distributed.
Lead Product(s): Hydroxyprogesterone Caproate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Makena
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 06, 2023
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena (34467 DU)
Details : Makena (hydroxyprogesterone caproate) is a synthetic progestin. The drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. It has been withdrawn and cannot lawfully be distri...
Product Name : Makena
Product Type : Hormone
Upfront Cash : Inapplicable
April 06, 2023
Details:
Acetylsalicylic Acid is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pre-Eclampsia.
Lead Product(s): Aspirin
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Recipient: Eastern Virginia Medical School
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 01, 2021
Lead Product(s) : Aspirin
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase IV
Recipient : Eastern Virginia Medical School
Deal Size : Inapplicable
Deal Type : Inapplicable
Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension (NCT04908982 DU)
Details : Acetylsalicylic Acid is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pre-Eclampsia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 01, 2021
Details:
FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Lead Product(s): Hydroxyprogesterone Caproate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Makena
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 14, 2020
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AMAG Files Submission in Response To the FDA’s Notice of Opportunity for a Hearing and Proposal ...
Details : FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm bir...
Product Name : Makena
Product Type : Hormone
Upfront Cash : Inapplicable
December 14, 2020
Details:
The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.
Lead Product(s): Ferumoxytol
Therapeutic Area: Hematology Brand Name: Feraheme
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition November 16, 2020
Lead Product(s) : Ferumoxytol
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Covis Pharma
Deal Size : $647.0 million
Deal Type : Acquisition
Covis Group Completes Acquisition of AMAG Pharmaceuticals (8790 D)
Details : The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.
Product Name : Feraheme
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : $647.0 million
November 16, 2020
Details:
Ciraparantag is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of undefined medical condition.
Lead Product(s): Ciraparantag
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Ciraparantag Holdings
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 20, 2020
Lead Product(s) : Ciraparantag
Therapeutic Area : Undisclosed
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Ciraparantag Holdings
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ciraparantag is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 20, 2020
Details:
With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not suitable or ineffective.
Lead Product(s): Ferumoxytol
Therapeutic Area: Hematology Brand Name: Feraheme
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition October 01, 2020
Lead Product(s) : Ferumoxytol
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Covis Pharma
Deal Size : $647.0 million
Deal Type : Acquisition
Covis Group Announces Agreement to Acquire AMAG Pharmaceuticals (7708 D)
Details : With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not su...
Product Name : Feraheme
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : $647.0 million
October 01, 2020
Details:
Dehydroepiandrosterone is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Atrophic Vaginitis.
Lead Product(s): Dehydroepiandrosterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Recipient: University of Arkansas
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 30, 2020
Lead Product(s) : Dehydroepiandrosterone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase II
Recipient : University of Arkansas
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dehydroepiandrosterone is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Atrophic Vaginitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 30, 2020
Details:
Under the terms of the termination agreement, all of AMAG’s rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin.
Lead Product(s): Bremelanotide Acetate
Therapeutic Area: Psychiatry/Psychology Brand Name: Vyleesi
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Recipient: Palatin Technologies
Deal Size: $16.3 million Upfront Cash: $12.0 million
Deal Type: Divestment July 27, 2020
Lead Product(s) : Bremelanotide Acetate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Recipient : Palatin Technologies
Deal Size : $16.3 million
Deal Type : Divestment
AMAG Pharmaceuticals Completes Divestment of Women’s Health Assets (6231 D)
Details : Under the terms of the termination agreement, all of AMAG’s rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin.
Product Name : Vyleesi
Product Type : Peptide, Unconjugated
Upfront Cash : $12.0 million
July 27, 2020
Details:
Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery or due to life-threatening or uncontrolled bleeding.
Lead Product(s): Ciraparantag
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Norgine
Deal Size: $290.0 million Upfront Cash: $30.0 million
Deal Type: Licensing Agreement July 23, 2020
Lead Product(s) : Ciraparantag
Therapeutic Area : Hematology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Norgine
Deal Size : $290.0 million
Deal Type : Licensing Agreement
Details : Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery or due to life-threatening or uncontro...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : $30.0 million
July 23, 2020
Details:
Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT).
Lead Product(s): Ciraparantag
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 12, 2020
Lead Product(s) : Ciraparantag
Therapeutic Area : Hematology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clot...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 12, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : FERIDEX I.V.
Dosage Strength : EQ 11.2MG IRON/ML
Packaging :
Approval Date : 1996-08-30
Application Number : 20416
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SUSPENSION;ORAL
Brand Name : GASTROMARK
Dosage Strength : EQ 0.175MG IRON/ML
Packaging :
Approval Date : 1996-12-06
Application Number : 20410
Regulatory Info : DISCN
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Inspections and registrations
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