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13 April 2015 | By Victoria White
DBV Technologies has announced that the FDA has granted Breakthrough Therapy Designation to Viaskin Peanut for children with peanut allergies...
9 April 2015 | By Victoria White
Santhera has announced that the FDA has granted Fast Track designation for Santhera's Raxone/Catena for the treatment of Duchenne Muscular Dystrophy...
1 April 2015 | By Victoria White
InVivo has announced a new clinical site in the ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury...
31 March 2015 | By Victoria White
Novartis has announced that the FDA has approved Jadenu tablets, a new oral formulation of Exjade® tablets, for the treatment of chronic iron overload...
31 March 2015 | By Victoria White
Amgen has announced that the FDA has accepted the sNDA of Kyprolis for the treatment of patients with relapsed multiple myeloma...
26 March 2015 | By Victoria White
Emergent BioSolutions has announced that the FDA has approved Anthrasil for treatment of inhalational anthrax in combination with antibacterial drugs...
18 March 2015 | By Victoria White
The US pharmaceutical market is forecast to increase to $548.4 billion by 2020 according to research and consulting firm GlobalData...
10 March 2015 | By Michael Rommerskirchen, Boehringer Ingelheim
Nowadays, professional quality and process data trending is key for science-based pharmaceutical development and manufacturing. Recently, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued revised process validation guidance to enforce recurring data analysis as a regulatory core requirement1,2: Periodic product and process monitoring, also known…
5 March 2015 | By Bristol-Myers Squibb
Bristol-Myers Squibb Company announced an approval of an additional indication for Opdivo (nivolumab) by the U.S. Food and Drug Administration...
2 March 2015 | By Bristol-Myers Squibb Company
Opdivo has the potential to be the first Immuno-Oncology agent approved for the treatment of advanced squamous non-small cell lung cancer...
23 February 2015 | By Eli Lilly & Company
Eli Lilly and Company announced a delay in the submission of basal insulin peglispro (BIL) to regulatory agencies beyond the first quarter of 2015...
19 February 2015 | By Roche
Roche announced the U.S. Food and Drug Administration has accepted and granted priority review for the company’s New Drug Application for cobimetinib in combination with Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma...
9 February 2015 | By GlobalData
Adam Dion, MS, GlobalData’s Healthcare Industry Analyst, says: “On 5 February 2015, just days after gaining US Food and Drug Administration (FDA) breakthrough approval for Ibrance (palbociclib) in breast cancer, Pfizer entered into an agreement to purchase generic drug maker Hospira..."
9 February 2015 | By Roche
Roche announced that the U.S. Food and Drug Administration approved Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy, in people with diabetic macular edema...
30 January 2015 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults...
