Non-small Cell Lung Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-08-20FDA Approved: VINORELBINE — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for VINORELBINE (vinorelbine) from Sagent Pharmaceuticals.
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FDA approval · 2020-07-27FDA Approved: VINORELBINE — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for vinorelbine by Sagent Pharmaceuticals, reflecting updated authorization for the drug.
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FDA approval · 2020-06-17FDA Approved: PEMFEXY — Supplemental Application (Eagle Pharmaceuticals, Inc.)
The FDA approved a supplemental application for PEMFEXY (pemetrexed) from Eagle Pharmaceuticals, Inc. under NDA 209472.
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FDA approval · 2020-05-08FDA Approved: RETEVMO — Original Application (Eli Lilly and Company)
FDA approved Retevmo (selpercatinib) from Eli Lilly in its original NDA. The approval covers RET fusion-positive non-small cell lung cancer …
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FDA approval · 2020-05-06FDA Approved: TABRECTA — Original Application (Novartis Pharmaceuticals Corporation)
FDA approved Tabrecta (capmatinib) under Original Application NDA213591 from Novartis for the treatment of adults with metastatic non-small …
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FDA approval · 2020-04-16FDA Approved: ERLOTINIB — Original Application (Zydus Lifesciences Limited)
FDA approved a generic erlotinib product from Zydus Lifesciences Limited under an original ANDA submission.
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FDA approval · 2020-03-05FDA Approved: CARBOPLATIN — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for carboplatin filed by Apotex Corp., authorizing changes to an approved generic product.
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FDA approval · 2020-02-08FDA Approved: PEMFEXY — Original Application (Eagle Pharmaceuticals, Inc.)
FDA approved PEMFEXY (pemetrexed) from Eagle Pharmaceuticals in an Original Application, adding a pemetrexed injection option.
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FDA approval · 2019-11-05FDA Approved: ERLOTINIB — Original Application (Armas Pharmaceuticals Inc.)
The FDA approved Armas Pharmaceuticals' original application (ANDA211960) for erlotinib hydrochloride as a generic version of erlotinib, for…
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FDA approval · 2019-11-05FDA Approved: ERLOTINIB — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' generic Erlotinib (ERLOTINIB) under an Original Application (ANDA), providing a generic option f…
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FDA approval · 2019-10-06FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for MEKINIST (trametinib) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2019-10-03FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)
The FDA approved a supplemental application for gemcitabine hydrochloride from Gland Pharma Limited. This approval enables the marketing of …
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FDA approval · 2019-09-05FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for docetaxel (docetaxel anhydrous) by Mylan Institutional LLC under ANDA 210072.
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FDA approval · 2019-08-15FDA Approved: ROZLYTREK — Original Application (Genentech, Inc.)
The FDA granted approval of Rozlytrek (entrectinib) in an original NDA for adult and pediatric patients with solid tumors that harbor NTRK g…
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FDA approval · 2019-06-27FDA Approved: ZIRABEV — Original Application (Pfizer Laboratories Div Pfizer Inc)
FDA approves ZIRABEV (bevacizumab-bvzr) from Pfizer as a biosimilar to Avastin under an Original Application. The approval covers multiple b…
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FDA approval · 2019-06-25FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approves a supplemental application for XALKORI (crizotinib) filed by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2019-04-01FDA Approved: DOCETAXEL — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Docetaxel from Dr. Reddy's Laboratories Inc., authorizing the generic product under the approved…
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FDA approval · 2019-03-18FDA Approved: ZYKADIA — Original Application (Novartis Pharmaceuticals Corporation)
FDA approved ZYKADIA (ceritinib) as an original new-drug approval for ALK-positive non-small cell lung cancer in patients who progressed on …
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FDA approval · 2019-03-13FDA Approved: DOCETAXEL ANHYDROUS — Supplemental Application (Meitheal Pharmaceuticals Inc)
The FDA approved a supplemental application from Meitheal Pharmaceuticals to market docetaxel anhydrous as a generic chemotherapy drug.
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FDA approval · 2018-12-21FDA Approved: ALUNBRIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ALUNBRIG (brigatinib) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2018-12-06FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for XALKORI (crizotinib) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2018-11-30FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for XALKORI (crizotinib) filed by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2018-11-02FDA Approved: LORBRENA — Original Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved Lorlatinib (LORBRENA) as the original application for treatment of ALK-positive metastatic non-small cell lung cancer in adults…
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FDA approval · 2018-09-27FDA Approved: VIZIMPRO — Original Application (U.S. Pharmaceuticals)
FDA approved VIZIMPRO (dacomitinib) under an Original Application (NDA) from U.S. Pharmaceuticals.
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FDA approval · 2018-08-28FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Tagrisso (osimertinib) submitted by AstraZeneca Pharmaceuticals LP to update/expand its labe…