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Inavolisib

New Drug Approvals

3] Inavolisib was approved for medical use in the United States in October 2024. [3] Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15] Food and Drug Administration (FDA). 3 November 2006. Retrieved 17 April 2025.

FDA
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Why most T-cell engagers fail – and how to fix it

Drug Target Review

As clinical adoption accelerates and regulatory approvals increase, there are now four FDA-approved T cell engagers and 17 bispecific antibody therapies available on the global market. Regulators are also providing clearer pathways for bispecifics, further fuelling TCE development. References PatSnap Synapse.

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The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care

The Premier Consulting Blog

Provides the Oncology Accelerated Approvals Database. International Projects Project Orbis An initiative for collaboration among international regulators Provide a framework for concurrent submission and review of oncology products among international partners, including Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the UK.

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Sepiapterin

New Drug Approvals

Accordingly, an object of the present invention is to provide a novel production method capable of stably supplying sepiapterin, lactoylpterin and tetrahydrolactoylpterin, which have recently been found to be useful as pharmaceuticals. Sepiapterin 17094-01-8 Sepiapterine CNSA-001 CJQ26KO7HP Molecular Weight 237.22 Br J Pharmacol.

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FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

The Pharma Data

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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Optimization of Pharmaceutical Dosage/ Formulation Chemistry

Pharmaceutical Development Group

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

The Pharma Data

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.