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Pfizer’s Ngenla finally secures FDA approval following a rocky road to market

Pharmaceutical Technology

Pfizer has announced that the FDA has approved Ngenla (somatrogon-ghla), a paediatric growth hormone deficiency treatment.

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Novartis’ Kisqali receives FDA approval to reduce the risk of breast cancer recurrence

BioPharma Reporter

Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive, HER2-negative) stage two or three early breast cancer, who are at high risk of cancer recurrence.

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Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The post Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval appeared first on.

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ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition

Pharmaceutical Technology

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. The post ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition appeared first on Pharmaceutical Technology.

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New Zepbound TV Commercial Inspires ‘Change’

XTalks

Related: Eli Lillys Zepbound Approved as First Treatment for Obstructive Sleep Apnea The commercial describes Zepbounds mechanism of action as a dual receptor against that works by activating two naturally occurring hormone receptors in [the] body [GLP-1 and GIP-1]. And when it comes to weight loss, change is good, it ends off saying.

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

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FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

The Pharma Data

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. The approval of NGENLA will be significant for children with growth hormone deficiency in the U.S. NYSE: PFE) and OPKO Health Inc.