Lynparza in combination with abiraterone granted priority review in US
New therapy is aimed at patients with metastatic castration-resistant prostate cancer
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Tag: Priority Review
Tecentriq wins FDA priority review for certain early NSCLC patients
Tecentriq is first and only cancer immunotherapy with positive Phase III results in adjuvant lung cancer setting
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US priority review for Forxiga in chronic kidney disease
AZ is aiming for approval in adults with and without type 2 diabetes
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Pfizer’s pneumococcal disease vaccine scores FDA priority review
Vaccine candidate previously scored fast-track and breakthrough therapy designations
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Priority review for Imfinzi’s less-frequent dosing regimen
AZ says approval would “simplify and improve treatment by enabling continuity of care while minimising the risk of exposure to infection in the healthcare setting”
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AZ scores Priority Review with Farxiga
The US FDA accepted a supplemental New Drug Application for the treatment.
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Priority Review awarded to Xtandi for prostate cancer
Back in February, the companies revealed results from the Phase III ARCHES trial in men with mHSPC.
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Novartis’ sickle cell drug wins FDA priority review
The governing body accepted the company’s Biologics License Application for prevention of vaso-occlusive crises.
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FDA Priority Review granted for GSK’s Zejula
There are around 7,500 new ovarian cancer cases in the UK every year.
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FDA grants Dupixent Priority Review for sinusitis
US regulators have accepted Sanofi’s Dupixent for Priority Review as a treatment for rhinosinusitis with nasal polyps.
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FDA Priority Review for Roche’s entrectinib in cancer treatment
Roche has announced that the FDA has granted Priority Review for entrectinib as a treatment for NTRK fusion-positive, locally advanced or metastatic solid tumours, and to treat metastatic ROS1-positive non-small-cell lung cancer.
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Bavencio combo gets FDA priority review for kidney cancer
The US Food and Drug Administration has accepted for priority review a supplemental Biologics License Application for Merck’s Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma (RCC).
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- MRM Health collaborates with Oncode Institute and Netherlands Cancer Institute
- Sobi to acquire Arthrosi Therapeutics, strengthening gout treatment pipeline
- Lindus Health and Quotient Sciences announce strategic partnership to accelerate drug development
- Title21 Health Solutions joins the Blood and Cells Advocacy Roster
- NADMED launches $30,000 metabolomics research award
