652 Results

Tecentriq fails in Phase III IMvigor010 study as an adjuvant (after surgery) monotherapy compared to observation in people with muscle-invasive urothelial cancer .-Genentech/Roche

 Added 23 hours ago

Roche announced that the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not...

FDA accepts filing of NDA for Lynparza for patients with metastatic castration-resistant prostate cancer . AstraZeneca + Merck Inc.

 Added 4 days ago

AstraZeneca and MSD Inc.,announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review...

FDA grants expanded indication for the use of the UroLift System to treat larger prostates, between 80cc and 100cc.-Teleflex Incorporated

 Added 17 days ago

Teleflex Incorporated announced that the FDA has granted the company an expanded indication for the use of its UroLift System...

Phase III JAVELIN Bladder 100 study met its primary endpoint to treat urothelial carcinoma .- Merck KGaA + Pfizer

 Added 18 days ago

Merck and Pfizer Inc. announced the Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival (OS)...

FDA grants 510(k) approval for Xvision Spine system an augmented reality guidance system for surgery. Augmedics

 Added 29 days ago

Augmedics, a pioneer in augmented reality surgical image guidance, has announced FDA 510(k) clearance and the U.S. launch of its...

FDA grants priority review to UGN 101 for upper tract urothelial cancer.- UroGen Pharma

 Added 1 month ago

UroGen Pharma announced the FDA accepted for filing and granted priority review for its New Drug Application (NDA) for UGN...

Positive results from phase III BLISS-LN trial of Benlysta to treat lupus nephritis.- GSK

 Added 1 month ago

GSK announced positive headline results for intravenous (IV) Benlysta (belimumab) in the largest controlled phase III study in active lupus...

FDA Advisory Committee recommends Keytruda for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC).

 Added 1 month ago

Merck Inc. announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted 9-4 in favor of recommending Keytruda,...

FDA grants accelerated approval to Padcev for the treatment of locally advanced or metastatic urothelial cancer. Seattle Genetics + Astellas

 Added 1 month ago

Seattle Genetics, Inc and Astellas Pharma Inc. announced that the FDA granted accelerated approval to Padcev for the treatment of...

FDA approves supplemental NDA for Xtandi in castration-sensitive prostate cancer.- Pfizer + Astellas

 Added 1 month ago

Pfizer and Astellas Pharma announced that the FDA has approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for...

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