FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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Shares of Dr. Reddy’s Laboratories Ltd. are surging this morning after the FDA approved its generic version of Suboxone (buprenorphine and naloxone) sublingual film for opioid addiction.
The U.S. Food and Drug Administration (FDA) granted Boston-based Albireo Pharma’s A4250 rare pediatric disease designation.
Following a meeting with the U.S. Food and Drug Administration Sage Therapeutics is seeing the goal line for potential expedited approval of its major depressive disorder (MDD) and postpartum depression (PPD) treatment, SAGE-217.
The medical device market was about $521.2 billion last year and is projected to hit $674.5 billion by 2022. Here’s a look at the top 10 medical device companies in the world this year.
The U.S. Food and Drug Administration (FDA) approved AbbVie and Roche’s combination of Venclexta in combination with Rituxan (rituximab) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion in patients who have received at least one previous therapy.
Ironwood Pharmaceuticals, headquartered in Cambridge, Massachusetts, announced the U.S. Food and Drug Administration (FDA) had granted its olinciguat (IW-1701) Orphan Drug Designation for sickle cell disease.
The U.S. Food and Drug Administration (FDA) approved Genentech’s Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).
There are generally two types of antidepressants on the market. They are selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). But there are still individuals who do not respond well to these drugs and the industry continues to work on developing better and alternative treatments for depression.
BioMarin Pharmaceutical received $20 million in milestone payments from Pfizer after the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved its applications for talazoparib.
As the 2018 BIO International Convention wraps up in Boston today, it kicked off with a fireside chat with Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA).