November 16, 2015
AstraZeneca’s Tagriss approved in USA
US FDA has approved TAGRISSO for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer.
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
November 11, 2015
Biofrontera’s business not affected by ongoing approval processes
Biofrontera has announced that there have been no new operational developments or matters which have arisen in relation to the ongoing approval processes or other operational aspects of the Company.
November 11, 2015
Allergan submits Prior Approval Supplement for RESTASIS
Allergan has submitted a Prior Approval Supplement (PAS) for RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05%, seeking approval of a Multi-Dose Preservative-Free (MDPF) presentation.
November 6, 2015
FDA approves Genvoya
FDA has approved Genvoya, a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide.
November 3, 2015
Janssen Applys to EMA to Expand Use of Imbruvica
Janssen-Cilag International NV announced on Tuesday the submission of a Type II variation application to the European Medicines Agency (EMA) seeking…
October 30, 2015
Lonsurf for colerectal cancer patients approved by FDA
United States Food and Drug Administration (FDA) has approved Lonsurf (trifluridine and tipiracil) tablets for the treatment of patients with metastatic colorectal cancer who have been previously…
October 29, 2015
FDA approved BMS’s Yervoy
U.S. Food and Drug Administration (FDA) has approved BMS’s Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy.
October 26, 2015
Strensiq: First approved treatment for perinatal
Strensiq is the first treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP) approved approved by FDA.
October 26, 2015
FDA approves Yondelis for metastatic liposarcoma
Food and Drug Administration (FDA) has approved YONDELIS (trabectedin) for the treatment of patients with unresectable (unable to be removed…
October 26, 2015
Medicine for treating pancreatic cancer approved in US
The U.S. Food and Drug Administration has approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat…