US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

With approval of AbbVie Inc./Genentech Inc.'s Venclexta as seventh under RTOR pilot, a roughly two-month median review time under the program could be taking shape.

In an interview with the Pink Sheet, Scott Gottlieb agrees with other ex-commissioners that there are benefits to an independent agency, but he thinks political forces would prevent it from ever happening.

As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.

US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Pfizer VP blames rebate strategies of innovators for difficulty in getting biosimilars on formularies while Express Scripts official says it is all about net cost during House hearing on lowering Rx drug prices.

On eve of congressional hearing, the pharmacy benefit manager assures Amgen that Repatha is available to its employees.

A proposal by the European Chemicals Agency that would add microplastics to the list of banned chemicals in the EU under its REACH regulation has come under attack by the US excipient industry. Officials argue that the proposal is misguided in that it considers polymers as microplastics and would unnecessarily restrict the availability of medicines that contain polymers in formulations.

There is growing recognition that the US FDA can use trade agreements to help confront the challenges of globalization and that these agreements can play an increasingly important role in fostering regulatory alignment and improving the quality of imports, agency official says.

The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.