Non-small Cell Lung Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-02-27FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for MEKINIST (trametinib) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2024-02-15FDA Approved: TEPMETKO — Supplemental Application (EMD Serono, Inc.)
The FDA approved a supplemental application for Tepmetko (tepotinib hydrochloride) from EMD Serono, Inc., expanding its approved indications…
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FDA approval · 2024-01-31FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA granted approval of a supplemental application for Tagrisso (osimertinib) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2023-12-11FDA Approved: PEMETREXED — Original Application (Solco Healthcare US, LLC)
FDA approved the original generic application for pemetrexed (PEMETREXED) by Solco Healthcare US, LLC.
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FDA approval · 2023-09-25FDA Approved: PEMETREXED — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for pemetrexed disodium (pemetrexed) submitted by Fresenius Kabi USA, LLC.
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FDA approval · 2023-09-19FDA Approved: DOCETAXEL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal's supplemental application to manufacture and market a generic docetaxel, enabling its supply for cancer treatment i…
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FDA approval · 2023-09-15FDA Approved: DOCETAXEL — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application for docetaxel from Gland Pharma Limited under an ANDA for the generic product.
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FDA approval · 2023-09-07FDA Approved: XALKORI — Original Application (Pfizer Laboratories Div Pfizer Inc)
The FDA granted original approval of XALKORI (crizotinib) for patients with ALK-positive non-small cell lung cancer.
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FDA approval · 2023-09-07FDA Approved: XALKORI — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for XALKORI (crizotinib) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2023-08-29FDA Approved: PEMETREXED DISODIUM — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved a supplemental application for pemetrexed disodium submitted by Dr. Reddy's Laboratories Inc.
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FDA approval · 2023-08-29FDA Approved: PEMETREXED — Supplemental Application (Accord Healthcare Inc.)
The FDA has approved Accord Healthcare Inc.'s supplemental application for pemetrexed (PEMETREXED), related to the approved pemetrexed produ…
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FDA approval · 2023-07-12FDA Approved: PEMETREXED — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for pemetrexed submitted by BluePoint Laboratories. This action approves the generic pemetrexed …
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FDA approval · 2023-06-21FDA Approved: TAGRISSO — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approves a supplemental application for Tagrisso (osimertinib) submitted by AstraZeneca, resulting in updated labeling and/or an expande…
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FDA approval · 2023-06-16FDA Approved: CARBOPLATIN — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for generic carboplatin. This action permits Apotex to market a generic carboplatin for…
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FDA approval · 2023-05-31FDA Approved: GEFITINIB — Original Application (Natco Pharma USA LLC)
The FDA approved Natco Pharma USA LLC's original ANDA for Gefitinib, enabling a generic version of the cancer drug to enter the market.
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FDA approval · 2023-05-22FDA Approved: PEMRYDI RTU — Original Application (Amneal Pharmaceuticals LLC)
FDA approved PEMRYDI RTU (pemetrexed disodium) from Amneal Pharmaceuticals as an Original Application, providing a ready-to-use formulation …
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FDA approval · 2023-04-26FDA Approved: GEFITINIB — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva Pharmaceuticals' generic Gefitinib under an Original Application (ANDA 208913). The approval enables Teva to market Gefiti…
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FDA approval · 2023-04-24FDA Approved: LUMAKRAS — Supplemental Application (Amgen Inc)
The FDA approved a supplemental application for LUMAKRAS (sotorasib) filed by Amgen Inc. This action updates the drug labeling to include th…
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FDA approval · 2023-04-21FDA Approved: PEMETREXED — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for pemetrexed disodium, enabling the generic pemetrexed product from Sandoz Inc. to be marketed…
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FDA approval · 2023-03-24FDA Approved: TABRECTA — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Tabrecta (capmatinib) by Novartis Pharmaceuticals Corporation, expanding the label for MET e…
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FDA approval · 2023-03-23FDA Approved: TEPMETKO — Supplemental Application (EMD Serono, Inc.)
The FDA approved a supplemental application for Tepmetko (tepotinib hydrochloride) submitted by EMD Serono, Inc., to update/expand the drug'…
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FDA approval · 2023-03-07FDA Approved: GEMCITABINE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic gemcitabine under an Original Application (ANDA). This marks the approval of a generic…
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FDA approval · 2023-02-27FDA Approved: PEMETREXED — Supplemental Application (Sagent Pharmaceuticals)
FDA approved a supplemental application for pemetrexed disodium from Sagent Pharmaceuticals, enabling continued availability of this generic…
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FDA approval · 2023-02-13FDA Approved: GEFITINIB — Original Application (Ingenus Pharmaceuticals, LLC)
The FDA approved Ingenus Pharmaceuticals' original application for Gefitinib, establishing a generic version of the cancer drug.
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FDA approval · 2023-01-20FDA Approved: LUMAKRAS — Supplemental Application (Amgen Inc)
FDA approved a supplemental application for LUMAKRAS (sotorasib) from Amgen, signaling a regulatory update to the drug's labeling/indication…