| Today’s Big NewsJun 18, 2025 |
| By Gabrielle Masson “I'm proud to report that we're on track to meet all the PDUFA targets, and that morale is good and improving at the agency,” FDA's Marty Makary said at this year’s BIO, an international convention that has attracted 23,000 attendees. |
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By Gabrielle Masson The FDA is introducing a new priority voucher program designed to shorten the drug review process time from 10 to 12 months down to one or two months, according to the agency. |
By Gabrielle Masson The Department of Health and Human Services is allegedly canceling clinical trial funding for biotechs with ties to certain foreign investors, Fierce Biotech has learned. |
By Kevin Dunleavy “This is probably one of the toughest years to predict,” Arda Ural, Ph.D., EY Americas Life Sciences Sector Leader, said on a conference call last week. |
By Gabrielle Masson Antares may be forging ahead with Scorpion's leadership team, but the company is adopting a different approach designed to account for the drastic transformation in both the biotech and macroeconomic environments. |
By Nick Paul Taylor PwC analysts have warned the speedy evolution of the Chinese biotech sector is creating “heightened risks related to IP security, regulatory compliance and strategic alignment.” |
By Angus Liu The biopharma industry has hit a setback in its ambition to leverage President Donald Trump’s “big, beautiful bill” to amend an Inflation Reduction Act provision currently affecting treatments for rare diseases. |
By Fraiser Kansteiner Following HHS secretary Robert F. Kennedy Jr.’s decision last week to purge the CDC’s Advisory Committee on Immunization Practices and appoint his own replacements, the 17 ousted experts are hitting back at the arguments behind the cull. |
By Angus Liu The value of priority review vouchers (PRVs) appears to be on the rise as concerns mount over declining supplies following the sunset of the rare pediatric disease PRV program. |
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| This week on "The Top Line," we unpack Fierce Medtech's Fierce 15 and spotlight startups reimagining healthcare. |
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