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FDA/Panel Decisions

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Roche (RHHBY) said Tuesday that the European Commission conditionally approved Polivy in combination with bendamustine plus MabThera for the treatment of adult patients with relapsed or refractory or R/R diffuse large B-cell lymphoma who are not candidates for a haematopoietic stem cell transplant. Conditional...

British drug major AstraZeneca (AZN, AZN.L) announced Monday that its Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation or ODD in the US. The approval is for the treatment of hepatocellular carcinoma or HCC, the most...

ANI Pharmaceuticals Inc. (ANIP) said it has received approval of the company's abbreviated new drug application from the U.S. Food and Drug Administration for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq. The current annual U.S. market for this product is approximately $75 million,...

AstraZeneca and Merck & Co. Inc. said that a supplemental New Drug Application for Lynparza in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line...

British drug major AstraZeneca (AZN, AZN.L) and Merck & Co., Inc. (MRK) announced that the US Food and Drug Administration has approved Lynparza (olaparib) as a 1st-line maintenance treatment of germline BRCA-mutated or gBRCAm metastatic pancreatic cancer. The drug is for adult patients with deleterious...

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