FDA
Public perception of the industry can be a bit confusing. Life Science Leader recently pulled together several biopharma executives for a round table discussion of the biopharma industry’s public perception—generally bad—and what might be able to do about it.
The U.S. Food and Drug Administration (FDA) approved ADMA Biologics’ Asceniv to treat Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents.
The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
EMD Serono, a unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) had approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
Gottlieb said the FDA believes there should be a premarket demonstration that a new opioid is superior to an already-approved opioid.
Novartis will quickly roll Mayzent out to U.S. physicians. The Swiss pharma giant plans to make the drug available within one week of the FDA approval.
Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy.
Hitachi Chemical Diagnostics, Inc., a global leader in multiplex allergy in vitro diagnostics, announced today that it received 510 clearance from the U.S Food and Drug Administration for its new high capacity allergy testing instrument, OPTIGEN® AP 3600TM.
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