Approvals
Since taking over the role of chief executive officer at Bothell, Wash.-based Alder BioPharmaceuticals in June 2018, Robert Azelby has maintained his focus on moving the company closer to launching its first commercial product in the migraine treatment space.
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before.
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
Phase 1/2 pheNIX Trial Would Represent First PKU Gene Therapy to Enter the Clinic
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.
PRESS RELEASES