Acromegaly
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-05EMA Authorised: Signifor (pasireotide) — Recordati Rare Diseases
Signifor (pasireotide) has been authorised in the EU for acromegaly and pituitary ACTH hypersecretion.
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EMA approval · 2026-08-03EMA Authorised: Palsonify (paltusotine hydrochloride) — Crinetics Pharmaceuticals Europe GmbH
Palsonify (paltusotine hydrochloride) has been authorised in Europe for acromegaly by Crinetics Pharmaceuticals Europe GmbH.
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EMA approval · 2026-06-15EMA Authorised: Palsonify (paltusotine hydrochloride) — Crinetics Pharmaceuticals Europe GmbH
Palsonify (paltusotine hydrochloride) has been authorised in Europe for acromegaly, with Crinetics Pharmaceuticals Europe GmbH as the MAH an…
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EMA approval · 2026-06-10EMA Authorised: Oczyesa (octreotide hydrochloride) — Camurus AB
Oczyesa (octreotide hydrochloride) has been authorised for use in the European Union, with Camurus AB as the marketing authorization holder,…
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EMA approval · 2025-12-03EMA Authorised: Oczyesa (octreotide hydrochloride) — Camurus AB
The EMA authorised Oczyesa (octreotide hydrochloride) from Camurus AB for the treatment of acromegaly.
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FDA approval · 2025-09-25FDA Approved: PALSONIFY — Original Application (Crinetics Pharmaceuticals, Inc.)
The FDA approved Palsonify (paltusotine) from Crinetics Pharmaceuticals as an original drug approval for the treatment of acromegaly. This m…
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EMA approval · 2025-02-27EMA Authorised: Somavert (pegvisomant) — Pfizer Europe MA EEIG
The EU has authorized Somavert (pegvisomant) for acromegaly.
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EMA approval · 2024-12-18EMA Authorised: Signifor (pasireotide) — Recordati Rare Diseases
The EMA authorised Signifor (pasireotide) for acromegaly and pituitary ACTH hypersecretion. Recordati Rare Diseases is the marketing authori…
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FDA approval · 2024-10-25FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application for Octreotide acetate submitted by Gland Pharma Limited.
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FDA approval · 2024-09-27FDA Approved: BYNFEZIA PEN — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved BYNFEZIA PEN (octreotide acetate) under an original NDA from Sun Pharmaceutical Industries. The product is an autoinjector pen …
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FDA approval · 2024-07-11FDA Approved: MYCAPSSA — Supplemental Application (Chiesi USA, Inc.)
The FDA approved a supplemental application for MYCAPSSA (oral octreotide) submitted by Chiesi USA, Inc.
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FDA approval · 2024-07-09FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a supplemental application for octreotide acetate (ANDA 203765) submitted by Heritage Pharmaceuticals d/b/a Avet Pharmaceut…
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FDA approval · 2024-07-09FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA granted supplemental approval for Octreotide Acetate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.).
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FDA approval · 2024-05-21FDA Approved: LANREOTIDE ACETATE — Original Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s original application for lanreotide acetate (lanreotide) to treat acromegaly and gastroenteropancreatic ne…
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FDA approval · 2023-12-05FDA Approved: OCTREOTIDE ACETATE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved OCTREOTIDE ACETATE as an original application, enabling a Teva-manufactured generic octreotide acetate.
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FDA approval · 2023-07-27FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC.
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FDA approval · 2023-06-30FDA Approved: OCTREOTIDE — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for octreotide acetate filed by Fresenius Kabi USA, LLC.
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FDA approval · 2023-06-22FDA Approved: OCTREOTIDE ACETATE — Original Application (Gland Pharma Limited)
FDA approved OCTREOTIDE ACETATE from Gland Pharma Limited via an Original Application (ANDA 216839), establishing a generic version of octre…
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FDA approval · 2023-06-13FDA Approved: OCTREOTIDE ACETATE — Original Application (Gland Pharma Limited)
FDA approved the original application for octreotide acetate, a generic product from Gland Pharma Limited. Octreotide acetate is indicated f…
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FDA approval · 2023-02-21FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for octreotide acetate by Mylan Institutional LLC under ANDA 079198, granting a supplemental approva…
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FDA approval · 2023-02-21FDA Approved: OCTREOTIDE ACETATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application to Heritage Pharmaceuticals (Avet) for octreotide acetate, a generic product, under an ANDA.
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FDA approval · 2022-11-08FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for bromocriptine mesylate from Sandoz Inc, approving a modification to an existing generic product'…
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FDA approval · 2022-04-27FDA Approved: BROMOCRIPTINE MESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for bromocriptine mesylate submitted by Zydus Pharmaceuticals USA Inc.
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FDA approval · 2021-12-17FDA Approved: LANREOTIDE ACETATE — Original Application (Cipla USA Inc.)
The FDA approved lanreotide acetate from Cipla USA Inc. as an original application, providing a generic option for the somatostatin analog u…
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FDA approval · 2021-08-20FDA Approved: SOMAVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approves a supplemental application for Somavert (pegvisomant) submitted by Pharmacia & Upjohn Company LLC. Somavert is used for tre…