Growth Hormone Deficiency
📧 Sign up to get email alerts when something new happens for Growth Hormone Deficiency.
Sign up freeTop drugs studied for this disease
-
EMA approval · 2026-08-21EMA Authorised: Ngenla (somatrogon) — Pfizer Europe MA EEIG
Ngenla (somatrogon) has been authorized by the EMA for growth and development indications in the European Union.
-
FDA approval · 2026-02-27FDA Approved: SOGROYA — Supplemental Application (Novo Nordisk)
The FDA approved a supplemental application for Sogroya (somapacitan) from Novo Nordisk, updating its labeling for use in growth hormone def…
-
EMA approval · 2025-12-16EMA Authorised: Ngenla (somatrogon) — Pfizer Europe MA EEIG
The European Medicines Agency has authorised Ngenla (somatrogon) from Pfizer Europe MA EEIG for treatment of pediatric growth hormone defici…
-
EMA approval · 2025-12-04EMA Authorised: Sogroya (somapacitan) — Novo Nordisk A/S
EMA authorised Sogroya (somapacitan) from Novo Nordisk A/S for growth hormone-related indications in the EU, including adults with growth ho…
-
FDA approval · 2025-07-25FDA Approved: SKYTROFA — Supplemental Application (Ascendis Pharma Endocrinology, Inc.)
FDA approved a supplemental application for SKYTROFA (lonapegsomatropin-tcgD) from Ascendis Pharma Endocrinology, Inc.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2025-07-09FDA Approved: NGENLA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for NGENLA (somatrogon-GHLA) submitted by Pfizer Laboratories Div Pfizer Inc.
-
FDA approval · 2025-07-09FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for OMNITROPE (somatropin) submitted by Sandoz Inc.
-
FDA approval · 2025-07-09FDA Approved: SKYTROFA — Supplemental Application (Ascendis Pharma Endocrinology, Inc.)
The FDA approved a supplemental application for SKYTROFA (lonapegsomatropin-tcgD) from Ascendis Pharma Endocrinology, Inc., through a supple…
-
FDA approval · 2025-07-09FDA Approved: SOGROYA — Supplemental Application (Novo Nordisk)
FDA approved a supplemental application for SOGROYA (somapacitan-beco) from Novo Nordisk.
-
EMA approval · 2025-02-12EMA Authorised: Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (Lonapegsomatropin) — Ascendis Pharma Endocrinology Division A/S
The European Medicines Agency authorised Skytrofa (lonapegsomatropin) from Ascendis Pharma Endocrinology Division A/S for growth hormone def…
-
FDA approval · 2025-01-31FDA Approved: SOGROYA — Supplemental Application (Novo Nordisk)
FDA approves a supplemental application for SOGROYA (somapacitan-beco) from Novo Nordisk.
-
FDA approval · 2025-01-31FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)
FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk.
-
FDA approval · 2024-07-05FDA Approved: NGENLA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for NGENLA (somatrogon-ghla) from Pfizer Laboratories Div Pfizer Inc.
-
EMA approval · 2024-05-13EMA Authorised: Ghryvelin (previously Macimorelin Aeterna Zentaris) (macimorelin acetate) — Atnahs Pharma Netherlands B.V.
The European Medicines Agency authorised Ghryvelin (macimorelin acetate) by Atnahs Pharma Netherlands B.V. as a new diagnostic drug for grow…
-
FDA approval · 2023-12-27FDA Approved: NGENLA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for NGENLA (somatrogon-ghla) submitted by Pfizer Laboratories Div Pfizer Inc, indicating an appr…
-
FDA approval · 2023-06-27FDA Approved: NGENLA — Original Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved NGENLA (somatrogon-ghla) from Pfizer as an original biologics license application to treat growth hormone deficiency, inclu…
-
FDA approval · 2022-10-20FDA Approved: SKYTROFA — Supplemental Application (Ascendis Pharma Endocrinology, Inc.)
The FDA approved a supplemental application for SKYTROFA (lonapegsomatropin-tcgD) from Ascendis Pharma Endocrinology, Inc., indicating an up…
-
FDA approval · 2021-10-01FDA Approved: SOGROYA — Supplemental Application (Novo Nordisk)
The FDA approved a supplemental application for SOGROYA (somapacitan) from Novo Nordisk.
-
FDA approval · 2021-08-25FDA Approved: SKYTROFA — Original Application (Ascendis Pharma Endocrinology, Inc.)
FDA approves SKYTROFA (lonapegsomatropin-tcgD) from Ascendis Pharma Endocrinology as an original application. It provides a once-weekly grow…
-
FDA approval · 2020-08-28FDA Approved: SOGROYA — Original Application (Novo Nordisk)
The FDA approved Sogroya (somapacitan) in an original application for adults with growth hormone deficiency, introducing a once-weekly long-…
-
FDA approval · 2020-03-09FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)
FDA approved a supplemental application for Norditropin (somatropin) by Novo Nordisk under BLA021148. The action pertains to changes approve…
-
FDA approval · 2020-01-08FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved Genotropin (somatropin) via a supplemental application submitted by Pfizer Laboratories Div Pfizer Inc.
-
FDA approval · 2018-01-30FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)
FDA approved a supplemental application for ZOMACTON (somatropin) by Ferring Pharmaceuticals. The action updates the product's indications o…
-
FDA approval · 2017-12-20FDA Approved: MACRILEN — Original Application (Aeterna Zentaris GmbH)
FDA approved MACRILEN (macimorelin acetate) from Aeterna Zentaris GmbH as an original application to diagnose adult growth hormone deficienc…
-
FDA approval · 2016-06-23FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)
FDA approves a supplemental application for Norditropin (somatropin) from Novo Nordisk, indicating changes to labeling and/or indications.