CVM warns Boehringer Ingelheim Animal Health USA that promotional communications for its Senvelgo make false and misleading claims that contradict the...
FDA publishes a draft guidance proposing select updates to its existing premarket cybersecurity guidance.
A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital marketing identifies several cross-cutting themes...
FDA and Instem researchers say 92% of Medical Device Reports filed between 2011 and 2021 involved device issues rather than patient adverse events.
Pfizer plans to share with FDA favorable data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with...
Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets as an adjunct to ins...
Acadia Pharmaceuticals stops developing pimavanserin for treating negative symptoms of schizophrenia based on disappointing top-line results from a Ph...
Federal Register notice: FDA makes available a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment.
