Multidrug-resistant 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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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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FDA approval · 2025-07-28FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved Janssen's supplemental application for SIRTURO (bedaquiline fumarate), enabling changes to the product labeling based on new da…
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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 · 2024-06-21FDA 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 · 2022-12-21FDA Approved: PRETOMANID — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Pretomanid, submitted by Viatris Specialty LLC.
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FDA approval · 2021-09-23FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP.
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FDA approval · 2020-05-27FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP, updating the drug's approv…
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FDA approval · 2020-01-06FDA 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 · 2019-12-03FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved Janssen's supplemental application for SIRTURO (bedaquiline fumarate), signaling an updated labeling and/or expanded use fo…
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FDA approval · 2019-08-15FDA 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 · 2019-08-14FDA Approved: PRETOMANID — Original Application (Viatris Specialty LLC)
FDA approved pretomanid under NDA 212862 from Viatris Specialty LLC. The approval addresses treatment options for drug-resistant tuberculosi…
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FDA approval · 2019-08-09FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approves Janssen's supplemental application for SIRTURO (bedaquiline fumarate).
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FDA approval · 2016-02-10FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP.
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FDA approval · 2015-12-09FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP.
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FDA approval · 2015-05-14FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) filed by Janssen Products, LP.
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FDA approval · 2014-10-17FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP. The action completes an additi…
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FDA approval · 2014-08-04FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP, likely updating the labeling or expand…
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FDA approval · 2014-03-19FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) from Janssen Products, LP, resulting in changes to the drug’s lab…
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EMA approval · 2013-12-20European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis
EMA recommends approval of a new medicine for multidrug-resistant tuberculosis, marking a potential new treatment option for this challengin…
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FDA approval · 2013-08-28FDA Approved: SIRTURO — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for SIRTURO (bedaquiline fumarate) submitted by Janssen Products, LP.