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tag biobusiness clinical trials fda business drug development

Antidepressant Approvals Could Herald New Era in Psychiatric Drugs
Bianca Nogrady | Oct 1, 2019 | 9 min read
The FDA has given the green light to the first major new classes of antidepressant therapies in decades, opening up new avenues for therapeutic development.
Illustration of light blue neurons with white amyloid plaques accumulating on their axons.
New Alzheimer’s Drug Slows Cognitive Decline in Clinical Trial
Dan Robitzski | Sep 28, 2022 | 2 min read
The Biogen-developed treatment, called lecanemab, appears to have a more clear-cut effect on slowing the disease than the company’s previous Alzheimer’s drug, Aduhelm.
Biotech Buys Autoimmune Firm for $7B
Kerry Grens | Jul 16, 2015 | 1 min read
Celgene has purchased Receptos, developer of an experimental multiple sclerosis drug.
Another Obesity Drug Trial Death
Kerry Grens | Dec 2, 2015 | 2 min read
A second patient taking an experimental medication to treat Prader-Willi Syndrome has died of blood clots.
Cannabis Biotech
Daniel Cossins | Dec 1, 2014 | 8 min read
As medical marijuana businesses set up shop across the U.S., a handful of companies are taking the pharmaceutical route, guiding cannabis-derived drugs through clinical trials.
a photo of the packaging for the drug Trikafta
FDA Approves New Cystic Fibrosis Drug
Shawna Williams | Oct 24, 2019 | 1 min read
The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.
PARP Inhibitors Are Improving the Outlook of Hard-to-Treat Cancers
Vicki Brower | Apr 1, 2018 | 9 min read
With three recent FDA approvals, and a number of Phase 3 trials ongoing, the drugs are seeing a surge in interest.
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blue and white sign for the entrance to the FDA that says U.S. Department of Health and Human Services Food and Drug Administration
Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews
Kerry Grens | Jun 7, 2021 | 2 min read
A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.
A gloved hand holds a tweezer and pulls a section of DNA away from a double helix
First Person Dosed in Novel Gene Editing Clinical Trial
Amanda Heidt | Jul 12, 2022 | 4 min read
The biotech company Verve Therapeutics launched the study with the aim of using base editing to treat a genetic condition that causes high cholesterol and increases a person's risk of developing cardiovascular disease.
New Automated Tool Monitors Clinical Trial Reporting
Diana Kwon | Feb 21, 2018 | 3 min read
The watchdog website FDAAA TrialsTracker names and shames human studies that breach the FDA’s requirements for reporting results.

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