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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-garraway
Genentech
European-medicines-agency
Global-product-development-at-genentech
Prescription-drug-user-fee
Global-product-development
European-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.

Japan
Canada
United-states
China
Susan-galbraith
Daiichi-sankyo
Ken-takeshita
European-union
Astrazeneca
Prescription-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-states
America
Abderrahim-oukessou
European-medicines-agency
Bristol-myers-squibb
Prescription-drug-user-fee
North-america
Fda
Fema
Nivolumab
Nsclc
Adjuvant-nivolumab

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.

Canada
Toronto
Ontario
Canadian
Adriano-marchese
Drug-administration
Prescription-drug-user-fee
Article-normal
Pharmaceuticals
Healthcare-life-sciences
Financial-performance
Share-price-movement-disruptions

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

FDA to review European-approved oral antibiotic for urinary tract infections
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United-states
Denmark
America
Henry-skinner
Tom-hadley
Drug-administration
World-health-organization
Action-fund
Infectious-diseases-society-of-america
United-kingdom-based
Utility-therapeutics
Health-organization

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