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…
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
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…
October 26, 2015
Cosentyx in Europe for psoriatic arthritis and ankylosing spondylitis
Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Cosentyx(TM) (secukinumab)…
October 16, 2015
FDA approved Praxbind for patients taking Pradaxa
The U.S. Food and Drug Administration on Friday granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
October 12, 2015
Quantum Pharma signs out-licensing deal for Aviticol in Germany
Quantum Pharma has signed an out-licensing agreement with a German pharmaceutical company for its first licensed product, a cholecalciferol 20 000IU capsule, marketed in the UK under the brand name Aviticol.
October 12, 2015
FDA: Opdivo approved for treating patients with advanced non-small cell lung cancer
The U.S. Food and Drug Administration (FDA) has today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
October 9, 2015
FDA Accepts Allergan’s Supplemental New Drug Application (sNDA) for DALVANCE
Allergan plc has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Allergan’s supplemental New Drug Application (sNDA), for MRSA.
October 6, 2015
USA: Aristada Approved to Treat Schizophrenia
Alkermes plcp has announced that the U.S. Food and Drug Administration (FDA) has approved Aristadatm (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
October 5, 2015
Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo + Yervoy Regimen
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
October 5, 2015
Avita expands Compassionate Use IDE program for ReCell
FDA allows Avita to expand its Compassionate Use Investigational Device Exemption (IDE) program for ReCell.