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Inavolisib Plus Palbociclib/Fulvestrant Earns FDA Priority Review for Advanced HR+/HER2–, PIK3CA+ Breast Cancer

The FDA granted priority review to inavolisib plus palbociclib/fulvestrant for HR-positive, HER2-negative, advanced breast cancer with PIK3CA mutations.

Levi garrawayEuropean medicines agencyGlobal product development at genentechPrescription drug user feeGlobal product developmentEuropean medicines

FDA Accepts BLA for Datopotamab Deruxtecan for Pretreated HR+/HER2– Metastatic Breast Cancer

The FDA has accepted a biologics license application for datopotamab deruxtecan in HR-positive, HER2-negative metastatic breast cancer.

United statesSusan galbraithDaiichi sankyoKen takeshitaEuropean unionPrescription drug user fee

Regulatory Filings Accepted for Perioperative Nivolumab Plus Chemotherapy in NSCLC

The FDA and EMA have accepted applications seeking the approval of neoadjuvant nivolumab/chemotherapy followed by surgery and adjuvant nivolumab in NSCLC.

United statesAbderrahim oukessouEuropean medicines agencyBristol myers squibbPrescription drug user feeNorth americaAdjuvant nivolumabNivolumab plus chemotherapy

Theratechnologies Shares Fall as FDA Continues to Review License Application for Tesamorelin

By Adriano Marchese Theratechnologies shares were sharply lower Tuesday morning after the company said U.S. regulators will continue to review its.

Adriano marcheseDrug administrationPrescription drug user feeArticle normalHealthcare life sciencesFinancial performanceShare price movement disruptionsCorporate industrial newsEquity marketsCommodity financial market newsContent typesFactiva filtersC amp ampe exclusion filterC amp ampe industry news filterShare price movementIndustrial news

FDA to review European-approved oral antibiotic for urinary tract infections

FDA to review European-approved oral antibiotic for urinary tract infections
umn.edu - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from umn.edu Daily Mail and Mail on Sunday newspapers.

United statesHenry skinnerTom hadleyDrug administrationWorld health organizationAction fundInfectious diseases society of americaUnited kingdom basedUtility therapeuticsHealth organizationInfectious diseases societyPrescription drug user fee

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