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FDA/Panel Decisions

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Merck (MRK) reported FDA accelerated approval for KEYTRUDA as monotherapy for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The approval was based on pooled data from KEYNOTE-158...

British drug major AstraZeneca Plc (AZN.L, AZN) and Merck & Co., Inc. (MRK) announced Tuesday that the European Commission has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. Lynparza is the only PARP inhibitor approved in the EU...

Amgen (AMGN) and Allergan plc (AGN) said that the U.S. Food and Drug Administration approved Kanjinti or trastuzumab-anns for all approved indications of the reference product, Herceptin or trastuzumab for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing...

Merck (MRK) said the FDA has approved KEYTRUDA as monotherapy in patients whose tumors express PD-L1 or in combination with platinum and fluorouracil for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma. The approval of the new...

Swiss drug major Roche (RHHBY) announced Tuesday that the US Food and Drug Administration or FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) or BR. The approval is for the treatment of adults with relapsed or refractory...

GlaxoSmithKline plc (GSK.L, GSK) announced Friday that the US Food and Drug Administration has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe. The approval allows patients or caregivers to administer it once every four weeks, after...

Eli Lilly and Co. (LLY) said that the U.S. Food and Drug Administration approved Emgality or galcanezumab-gnlm injection (300 mg) for the treatment of episodic cluster headache in adults. The company noted that Emgality will be available to patients for pickup at retail pharmacies. The U.S. list price...

Boehringer Ingelheim and Eli Lilly and Co. (LLY) announced Tuesday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose triple combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment...

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