Vanda Pharmaceuticals criticizes FDA for failing to approve the companys NDA for tradipitant to treat the symptoms of gastroparesis.
Annes Daye says it is pulling its CBD-coated tampons from the U.S. market following receipt of an FDA Warning Letter.
FDA publishes a draft guidance on developing drugs for optical imaging for three purposes.
FDA accepts for priority review a Dizal NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic non-small cell lung ...
FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.
FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.
FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or cleared medical produ...
Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a statistically signific...
