The Push for Generics Challenges Manufacturers

FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.

FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.

FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.

Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.

Univar Solutions scientists developed a lidocaine cream built on starch, sorbitol, coconut oil, and beeswax that matched a commercial benchmark on viscosity, assay, and hydration.

Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.

Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.

Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.