Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds...

The hiring and departure data provide more evidence of the extent of the Trump Administration’s efforts to shrink the FDA workforce through cuts and voluntary departures.

An AI tool developed by the Office of Prescription Drug Promotion for reviews is believed to still lack generative capabilities, said former senior staffer Jason Cober, who also raised concerns about...

Pink Sheet reporter and editors discuss the FDA’s role in the Astra Zeneca Most Favored Nation drug pricing deal and the Justice Department interpreting the off-label promotion laws differently than...

The National Health Service said the roll out of ViiV Healthcare’s Apretude would bring England closer to its aim of becoming the first country in the world to end HIV transmissions by 2030.

The European Medicines Agency’s human medicines committee, the CHMP, has recommended Insmed’s Brinsupri and Sanofi’s Wayrilz for pan-EU approval but turned down Sanofi’s Rezurock based on trial...

A combination of two individual IVF treatments, Pergoveris has the potential to be a lower cost option in the US, one of the qualifications the FDA wants in a National Commissioner's Priority Voucher...

Panelists at the BioFuture conference discussed the potential opportunities the government shutdown creates for the FDA to improve flexibility and efficiency.

Formal meetings like application orientation sessions or patient listening sessions are becoming increasingly important as the FDA schedules fewer advisory committee meetings for applications,...

Can ethics committees standardize consent without sacrificing ethical depth? A Belgian study urges balance between efficiency and meaningful dialog.

The UK’s commercial environment is “incredibly strained,” meaning that there is little money left to pay for innovative medicines. The ABPI’s chief executive says a “fundamental transformation” will...

Kashiv BioSciences/Alvotech/Advanz Pharma’s biosimilar version of omalizumab is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing...

The Trump Administration’s anti-DEI rhetoric does not appear to have dramatically impacted US FDA communications in guidance about assuring representative patient populations.

Pfizer and AstraZeneca must be confident that drug price reductions in Medicaid and through direct-to-consumer channels will not lead to deeper discounts in the 340B program.

The US government shutdown is challenging HRSA’s ability to advance the 340B pilot program on schedule.

Corcept’s relacorilant, Ascendis’s navepegritide and J&J’s icotrokinra are all investigational products that are now under review for potential marketing authorization in the EU as well as in the US.

The European Medicines Agency makes a case for developing the first EU-wide guideline to clarify regulatory expectations for idiopathic pulmonary fibrosis medicines, with a focus on standardizing...

China's NMPA announces new measures designed to speed up access to imported medicines already launched abroad ahead of their final formal regulatory approval in China.

The UK’s revamped Innovative Licensing and Access Pathway has reached a significant milestone, with three rare disease therapies clearing the first step of securing innovation passports.

Recent Justice Department filings may suggest it is rethinking allowances for drug manufacturers to communicate scientific information on unapproved uses to healthcare providers.