Regulatory Affairs Professionals Society

FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
RAPS

An Increasing Number of Companies Are Using a Once-Obscure FDA Drug Approval Pathway

Companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US Food and Drug Administration (FDA), a review by Thompson ...
Monthly Prescribing Reference

FDA Drug Approval Decisions Expected in May 2026

The FDA granted Priority Review to the supplemental BLA (sBLA) for efgartigimod alfa-fcab for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia ...
Hosted on MSN

Regulatory round-up: A month of key FDA approvals for cancer drugs

It has been a big month for the oncology space, underpinned by several US approvals in haematological and solid tumour indications – with BeOne Medicines, Taiho Oncology and Arvinas all securing the ...
Scientific American

RFK, Jr., puts psychedelics on fast track to FDA review and approval

On Friday the U.S. Food and Drug Administration announced it is fast-tracking the review and approval process for three companies studying psilocybin, the active psychedelic compound in magic ...