Tuberculosis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-09EMA Authorised: Dovprela (previously Pretomanid FGK) (pretomanid) — Mylan IRE Healthcare Limited
EMA authorised Dovprela (pretomanid) for multidrug-resistant tuberculosis; orphan medicine.
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EMA approval · 2026-06-03EMA Authorised: Sirturo (bedaquiline fumarate) — Janssen-Cilag International N.V.
EMA authorises Sirturo (bedaquiline fumarate) for multidrug-resistant tuberculosis.
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EMA approval · 2026-03-18EMA Authorised: Deltyba (Delamanid) — Otsuka Novel Products GmbH
The European Medicines Agency authorised Deltyba (delamanid) for treatment of multidrug-resistant tuberculosis, with Otsuka Novel Products G…
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EMA approval · 2026-02-19EMA Authorised: Dovprela (previously Pretomanid FGK) (pretomanid) — Mylan IRE Healthcare Limited
The European Medicines Agency authorised Dovprela (pretomanid) for tuberculosis, including multidrug-resistant tuberculosis, with orphan med…
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FDA approval · 2026-01-27FDA Approved: PRIFTIN — Supplemental Application (sanofi-aventis U.S. LLC)
The FDA approved a supplemental application for PRIFTIN (rifapentine) from Sanofi-Aventis U.S. LLC.
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EMA approval · 2025-11-24EMA Authorised: Sirturo (bedaquiline fumarate) — Janssen-Cilag International N.V.
EMA authorised Sirturo (bedaquiline fumarate) for treatment of tuberculosis, including multidrug-resistant tuberculosis. The decision date i…
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EMA approval · 2025-10-24EMA Authorised: Siiltibcy (Mycobacterium tuberculosis derived antigens (rdESAT‑6 and rCFP‑10)) — Serum Life Science Europe GmbH
EMA has authorised Siiltibcy, a tuberculosis diagnostic product using M. tuberculosis–derived antigens rdESAT-6 and rCFP-10, developed by Se…
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FDA approval · 2025-10-08FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for Rifadin IV (rifampin) submitted by Sanofi-Aventis U.S. LLC. This action covers the intraveno…
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for isoniazid submitted by Chartwell RX, LLC.
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (CMP Pharma, Inc.)
The FDA approved CMP Pharma's supplemental application for isoniazid, authorizing changes to an already approved generic product for tubercu…
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for isoniazid submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (Marlex Pharmaceuticals, Inc.)
FDA approved a supplemental application for Isoniazid from Marlex Pharmaceuticals, approving changes to the previously approved product.
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for isoniazid (isoniazid) submitted by Chartwell RX, LLC.
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Isoniazid from Teva Pharmaceuticals USA, Inc. (isoniazid), indicating regulatory approval fo…
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FDA approval · 2025-02-05FDA Approved: ISONIAZID — Supplemental Application (Sandoz Inc)
FDA approves a supplemental application for isoniazid from Sandoz Inc, updating regulatory approval for an existing product.
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FDA approval · 2025-01-30FDA Approved: ISONIAZID — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for isoniazid from Chartwell RX, LLC, authorizing changes to the previously approved product.
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FDA approval · 2025-01-29FDA Approved: ISONIAZID — Supplemental Application (CMP Pharma, Inc.)
FDA approved CMP Pharma, Inc.'s supplemental application for isoniazid, updating the approved product under an abbreviated new drug applicat…
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FDA approval · 2025-01-27FDA Approved: ISONIAZID — Supplemental Application (Marlex Pharmaceuticals, Inc.)
FDA approved a supplemental application for isoniazid from Marlex Pharmaceuticals, Inc.
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FDA approval · 2024-11-22FDA Approved: PRETOMANID — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Pretomanid submitted by Viatris Specialty LLC, updating its labeling to reflect its use in drug-…
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FDA approval · 2024-11-22FDA Approved: ISONIAZID — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for the generic drug isoniazid submitted by Chartwell RX, LLC.
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FDA approval · 2024-10-24FDA Approved: ISONIAZID — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for isoniazid submitted by Teva Pharmaceuticals USA, Inc. (ANDA 080937).
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FDA approval · 2024-10-24FDA Approved: ISONIAZID — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for isoniazid from Teva Pharmaceuticals USA, Inc., confirming regulatory clearance for this gene…
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FDA approval · 2024-06-21FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved Janssen's supplemental application for SIRTURO (bedaquiline fumarate), updating the labeling to reflect the approved changes.
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FDA approval · 2023-10-12FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP.
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FDA approval · 2023-08-16FDA Approved: RIFADIN IV — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application to add an intravenous formulation of rifampin (RIFADIN IV).