The U.S. and U.K. have reached an agreement in principle that lifts U.K. net prices for new innovative medicines by 25 percent, caps VPAG repayments at 15 percent from 2026 onward, and exempts U.K.-origin pharmaceutical and medical goods from Section 232 tariffs.
Biogen has earned a positive CHMP opinion for its high-dose nusinersen regimen, supported by strong DEVOTE study results showing major motor improvements and reduced mortality risk in SMA patients.
CHMP’s November 2025 meeting delivered 10 new drug approvals, four indication extensions, and several high-profile withdrawals, highlighting continued momentum in gene therapy, oncology, immunology, and diagnostics.
A stylized U.S. – Swiss handshake over rising economic indicators reflects the sweeping new trade deal tariffs slashed to 15% and Switzerland pledging $200B in U.S. investment through 2028. (Editorial Illustration) The United States and Switzerland have announced a major framework trade agreement that will see Washington slash tariffs on Swiss imports from 39% to … Read more
FDA officials Vinay Prasad and Marty Makary have unveiled a new “plausible mechanism pathway” designed to accelerate bespoke gene-editing therapies.
Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.) FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies The U.S. Food and Drug Administration (FDA) has announced a significant … Read more
Malaysia’s acceptance of U.S. FDA certificates under the new U.S.–Malaysia reciprocal trade deal.
UK braces as drug pricing shifts dramatically in market access landscape.
Sanofi’s Tzield gains FDA review for stage 3 T1D.
FDA defines biosimilar PAS & CBE under BsUFA III