Renal Cell Carcinoma
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-03-03EMA Authorised: Torisel (temsirolimus) — Pfizer Europe MA EEIG
EMA authorised temsirolimus (Torisel) for renal cell carcinoma and mantle cell lymphoma in the EU, with Pfizer Europe MA EEIG as the marketi…
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FDA approval · 2025-02-14FDA Approved: SUNITINIB MALATE — Original Application (Novadoz Pharmaceuticals LLC)
The FDA approved an original generic application for sunitinib malate from Novadoz Pharmaceuticals LLC. This approval provides a generic opt…
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FDA approval · 2025-02-11FDA Approved: TEMSIROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's supplemental application for temsirolimus, bringing a generic version to the market. The approval covers te…
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FDA approval · 2025-01-30FDA Approved: FOTIVDA — Supplemental Application (AVEO Pharmaceuticals, Inc.)
FDA approved a supplemental application for FOTIVDA (tivozanib) filed by AVEO Pharmaceuticals, Inc.
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EMA approval · 2025-01-22EMA Authorised: Inlyta (axitinib) — Pfizer Europe MA EEIG
EU authorisation granted for Inlyta (axitinib) for renal cell carcinoma. The marketing authorisation holder is Pfizer Europe MA EEIG.
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FDA approval · 2024-12-04FDA Approved: PAZOPANIB — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's pazopanib ANDA 219034, a generic version of pazopanib. It is indicated for unresectable or metastati…
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FDA approval · 2024-11-26FDA Approved: SORAFENIB — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for sorafenib submitted by Dr. Reddy's Laboratories Inc. This action provides supplemental approval …
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FDA approval · 2024-11-08FDA Approved: PAZOPANIB — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)
FDA approved a supplemental application for pazopanib from Sun Pharmaceutical Industries, Inc. (ANDA 215837).
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FDA approval · 2024-08-06FDA Approved: FOTIVDA — Supplemental Application (AVEO Pharmaceuticals, Inc.)
FDA approved a supplemental application for Fotivda (tivozanib) submitted by AVEO Pharmaceuticals, Inc.
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FDA approval · 2024-07-16FDA Approved: INLYTA — Supplemental Application (U.S. Pharmaceuticals)
The FDA has approved a supplemental application for INLYTA (axitinib) submitted by U.S. Pharmaceuticals.
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FDA approval · 2024-04-30FDA Approved: EVEROLIMUS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Everolimus submitted by Hikma Pharmaceuticals USA Inc. This action updates approved labeling…
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FDA approval · 2024-04-23FDA Approved: PAZOPANIB — Original Application (Novugen Pharma (USA) LLC.)
FDA approved pazopanib hydrochloride as an original ANDA, enabling a generic version of pazopanib.
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FDA approval · 2024-03-05FDA Approved: SORAFENIB TOSYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA granted a supplemental approval for sorafenib tosylate (generic sorafenib) by Mylan Pharmaceuticals Inc., allowing the generic product t…
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FDA approval · 2023-10-19FDA Approved: PAZOPANIB — Original Application (Apotex Corp.)
FDA approved an original Abbreviated New Drug Application for Pazopanib by Apotex Corp., providing a generic version of the cancer drug Pazo…
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FDA approval · 2023-10-19FDA Approved: PAZOPANIB — Original Application (Teva Pharmaceuticals, Inc.)
FDA approval of a generic pazopanib product from Teva Pharmaceuticals under an Original Application (ANDA 217517).
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FDA approval · 2023-10-19FDA Approved: PAZOPANIB — Original Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)
FDA approved Sun Pharmaceutical's pazopanib as an original ANDA (generic) approval. The approval covers a generic version of pazopanib for t…
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FDA approval · 2023-09-29FDA Approved: PROLEUKIN — Supplemental Application (Iovance Biotherapeutics, Inc)
The FDA has approved a supplemental application for PROLEUKIN (aldesleukin) submitted by Iovance Biotherapeutics, Inc.
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FDA approval · 2023-09-12FDA Approved: SORAFENIB — Supplemental Application (Yabao Pharmaceutical Co., Ltd. Beijing)
FDA approved a supplemental application for Sorafenib by Yabao Pharmaceutical Co., Ltd. Beijing under an ANDA.
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FDA approval · 2023-09-12FDA Approved: SORAFENIB — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a supplemental application for Sorafenib from Teva Pharmaceuticals, indicating regulatory action for the generic product. Soraf…
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FDA approval · 2023-08-21FDA Approved: SUNITINIB MALATE — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental application for SUNITINIB MALATE (sunitinib malate) filed by NorthStar RxLLC.
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FDA approval · 2023-08-21FDA Approved: SUNITINIB MALATE — Original Application (Novugen Pharma (USA) LLC.)
FDA approves a generic version of sunitinib malate from Novugen Pharma (USA) LLC under an Original Application (ANDA 218012).
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EMA approval · 2023-07-17EMA Authorised: Fotivda (tivozanib) — Recordati Netherlands B.V.
Fotivda (tivozanib) has been authorised by the EMA for use in carcinomas of the renal cell type.
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FDA approval · 2023-04-12FDA Approved: SORAFENIB — Original Application (Torrent Pharmaceuticals Limited)
The FDA approved Torrent Pharmaceuticals' original ANDA for sorafenib, a generic version of Nexavar, expanding access to the cancer therapy.
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FDA approval · 2022-11-09FDA Approved: SORAFENIB — Original Application (Yabao Pharmaceutical Co., Ltd. Beijing)
FDA approved a generic sorafenib product from Yabao Pharmaceutical Co., Ltd. Beijing (ANDA 209050). The approval covers the same indications…
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FDA approval · 2022-09-22FDA Approved: INLYTA — Supplemental Application (U.S. Pharmaceuticals)
The FDA approved a supplemental application for INLYTA (axitinib) filed by U.S. Pharmaceuticals, updating the drug’s labeling.