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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]

FDA 62
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PRITELIVIR MESYLATE

New Drug Approvals

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Clinical Trials: Pritelivir mesylate is currently under extensive study to evaluate its efficacy and safety profile, with promising results in early clinical trials. 316 (23): 2495–2503.

Virus 62
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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]

FDA 57
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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. 28 May 2025. Archived from the original on 29 May 2025. Retrieved 29 May 2025 – via Business Wire. Beck B, et al.

FDA 48
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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 Randomized clinical trials have been published to compare landiolol with placebo< [21] [22] [23] diltiazem, [24] and amiodaron [25] in patients with or without heart failure. AOP Health.

FDA 62
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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

Science 40
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2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Broad Institute

In the early 2000s, both teams began preparing for clinical trials. 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. We treated our first patient with CD19 CAR T cells back in 2007.

Therapies 119