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Latest posts

Last updated about 4 hours ago

Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot

about 4 hours ago

Amid a period of great upheaval at the agency, the FDA has...

After patient death, Sarepta and Roche pause 3 trials of gene therapy Elevidys in Europe

about 8 hours ago

In response to a request from the European Medicines Agency following the...

Novo's commercial strategy head hits the exit, prompting a slew of executive team shakeups

about 8 hours ago

Camilla Sylvest is stepping down from her role as executive vice president...

Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors

about 8 hours ago

The FDA's approval for Novartis' atrasentan in the kidney disease IgAN means...

Nxera Pharma appoints AstraZeneca alum as inaugural commercial chief

about 8 hours ago

As Nxera Pharma proceeds into the “next era” implied by its name—following...

FDA inspection operations face risk of further disruption amid mass HHS layoffs: report

about 9 hours ago

While the FDA’s inspection figures for drug manufacturing facilities have yet to...

Havas Health adds execs at nascent New York agency as Real Chemistry strengthens in Europe

about 10 hours ago

Agencies made moves on both sides of the Atlantic Wednesday, with Havas...

As Trump's 'Liberation Day' tariffs seem to spare pharmaceuticals, threat of industry-specific duties and loopholes persists

about 24 hours ago

On Wednesday, President Donald Trump unveiled another wave of tariffs but did...

With biosimilar competition looming, Roche takes a hit with failure of high-dose Ocrevus

1 day ago

With its multiple sclerosis powerhouse Ocrevus expected to lose patent protection by...

For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty

1 day ago

To innovators in the cell and gene therapy field, Peter Marks’ exit...

Japan's Marubeni takes on Sumitomo's Asia pharma business to make new company in deal worth up to $480M

1 day ago

Japanese conglomerate Marubeni is getting a 60% stake in the new company...

FDA taps insider Scott Steele to lead CBER on acting basis after Peter Marks departure

1 day ago

Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has...