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FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
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Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Greg Grunberg, who has appeared in multiple Star Wars projects, has partnered with Jazz Pharmaceuticals to bring “The Care Giver”, a video web series, to life.
Results of the Phase III trial showed that Evusheld protected against progression to severe COVID-19 or death in the early outpatient treatment of mild-to-moderate COVID-19.
Novo Nordisk and Eli Lilly came under legal scrutiny this week, while BMS forked over $11 million to settle claims over anticompetitive tactics.
Aldeyra Therapeutics reported that its reproxalap hit the mark in the Phase III Tranquility-2 study for dry eye disease. The drug showed statistical superiority for its two primary endpoints.
Ensysce Biosciences is developing solutions that make opioids safer, and virtually impossible to abuse. BioSpace spoke with CEO Lynn Kirkpatrick about the company’s novel technology.
More oncology firms presented positive developments in their respective cancer research programs at the 2022 ASCO annual meeting this week.
Sales and marketing roles in the life sciences field are in high demand. To help with your job search, we’ve compiled a guide to sales and marketing jobs in the life sciences industry.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
Calls for a reform of drug prices have become a regular occurrence, particularly in the midst of political campaigns. Yet a new report shows the median price of a new drug launched in 2021 was $180,000.