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Gepirone

New Drug Approvals

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] The FDA rejected approval for gepirone in 2002 and 2004. [5]

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Seladelpar

New Drug Approvals

1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1] 1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1]

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Inavolisib

New Drug Approvals

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 1, 2007, 41-44) (2.30 19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3]

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FDA More Selective About Convening Advisory Committee Panels During Pandemic | 2021-01-18

The Pharma Data

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

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Acoltremon

New Drug Approvals

PMID 19095656. ^ “Alcon Announces FDA Approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease” (Press release). 2007 Mar;41(3):285-94. 284 (7): 4102–4111. doi : 10.1074/jbc.M806651200. 28 May 2025. Archived from the original on 29 May 2025.

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Landiolol

New Drug Approvals

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). 24 August 2022. AOP Health.

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2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Broad Institute

In 2007, Sadelain and Rivire treated their first patient with leukemia, and in 2009, published details on how they manufactured personalized CAR T cells to treat patients with aggressive leukemia. After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.)

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