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FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight

The U.S. Food and Drug Administration recently approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.

United-states , American , Novo-nordisk , John-sharretts , Division-of-diabetes , Drug-administration , Lipid-disorders , Drug-evaluation , Multiple-endocrine-neoplasia , Priority-review ,

Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs

Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs

Guidance-issuing-office , Drug-administration , Docket-number , Drug-evaluation , Composition-statements , Corresponding-statement ,

A Milestone in Facilitating the Development of Safe and Effective Biosimilars

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.

Hilary-marston , Patrizia-cavazzoni , Sarah-yim , Drug-administration , Association-of-accessible-medicines , New-drug-office , Therapeutic-biologics , Chief-medical-officer , Drug-evaluation , Biologics-price-competition , Innovation-act , Accessible-medicines

FDA Approves New Antibiotic To Treat Urinary Infections In Women

FDA Approves New Antibiotic To Treat Urinary Infections In Women
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Washington , United-states , New-york , Peter-kim , Dennis-riedl , New-york-times , Division-of-anti , United-utility-therapeutics-ltd , Drug-administration , Urinary-tract-infections , United-kingdom-based-utility-therapeutics-ltd , Drug-evaluation

FDA Roundup: April 26, 2024

FDA Roundup: April 26, 2024
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China , United-states , Pmrs-pmcs , Patrizia-cavazzoni , Sarah-yim , Hilary-marston , Human-services , Office-of-media-affairs , Accelerator-applications-united-states-inc , Day-one-biopharmaceuticals-inc , Us-department-of-health , Cardinal-health

FDA Approves New Antibiotic To Treat Urinary Infections In Women

FDA Approves New Antibiotic To Treat Urinary Infections In Women
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New-york , United-states , Peter-kim , Division-of-anti , United-utility-therapeutics-ltd , Drug-administration , New-york-times , Urinary-tract-infections , United-kingdom-based-utility-therapeutics-ltd , Drug-evaluation ,

FDA approves new medication for uncomplicated urinary tract infections in women

The newly approved oral medication Pivya provides women with another option for treating uncomplicated urinary tract infections, the U.S. Food and Drug Administration announced Wednesday.

Peter-kim , Drug-administration , Drug-evaluation , Urinary-tract-infections , Acterial-infections , Ood-and-drug-administration , Eter-kim ,

ASCO 2024 | Ascentage Pharma to Present Four Studies, Including an Oral Report Featuring the Latest Data of Olverembatinib in SDH-Deficient GIST

ASCO 2024 | Ascentage Pharma to Present Four Studies, Including an Oral Report Featuring the Latest Data of Olverembatinib in SDH-Deficient GIST
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Guangdong , Jilin , China , Hangzhou , Zhejiang , United-states , Hong-kong , Suzhou , Jiangsu , Melbourne , Victoria , Australia

Santhera Pharmaceuticals Holding AG: Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

Santhera Pharmaceuticals Holding AG: Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May
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China , Austria , France , United-kingdom , Germany , Spain , Pratteln , Switzerland-general- , Switzerland , Highbridge , Somerset , United-states

Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on April 25, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May 2023 financial key figures: Revenue from contracts with customers of CHF 103.4 million (2022: CHF 7.5 million) Net result of CHF 54.8 million (2022: CHF -71.1 million) Cash flow from operating

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