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Regulatory
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Woman holding display of business, regulatory icons

Little interest shown in premarket use of MDSAP audits

Feb. 27, 2025
By Mark McCarty
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.
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Bipartisan PBM reforms back on the congressional table

Feb. 26, 2025
By Mari Serebrov
The U.S. Congress is turning its attention, once again, to bipartisan pharmacy benefit manager (PBM) reforms, after efforts to rein in PBM practices died with the 118th Congress. With an eye on finally getting them passed, the House Energy and Commerce Committee kicked off the process with a Feb. 26 hearing that was supposed to be focused on the reform legislation the committee approved last year and follow-on legislation to rein in harmful PBM practices.
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Illustration of tumor on kidney

FDA accepts Telix BLA for kidney cancer imaging agent

Feb. 26, 2025
By Tamra Sami
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
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U.S. Supreme Court

Loper Bright no free pass where FDA’s LDT rule is concerned

Feb. 26, 2025
By Mark McCarty
The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.
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U.S. Capitol building, Washington D.C.

FDA’s LDT rule, CDS guidance combine to complicate regulatory life

Feb. 26, 2025
By Mark McCarty
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals January 2025

Astrazeneca, Vertex, Axsome secure US FDA approvals in January

Feb. 25, 2025
By Amanda Lanier
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
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Various pills laid across a target

Pharmaceuticals named as tariff target, starting at 25%

Feb. 25, 2025
The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”
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New admin toes the Biden line on Rx price negotiations

Feb. 25, 2025
By Mari Serebrov
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
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Hand crossing out employees on organizational chart

US lawmakers tell Kennedy: No more ‘indiscriminate’ terminations

Feb. 24, 2025
By Mari Serebrov
Citing recent executive orders that suggest additional cuts to the federal workforce may be in the offing, U.S. Sens. Patty Murray, D-Wash., and Jeanne Shaheen, D-N.H., wrote to Health and Human Services Secretary Robert Kennedy urging him to end “indiscriminate cuts that will cause lasting harm to FDA’s public health mission” and to protect the agency’s statutory obligations.
Read More
SonioAI

US FDA clears Sonio Suspect for fetal anomaly detection

Feb. 24, 2025
By Annette Boyle
The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.
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