The U.S. Food and Drug Administration (FDA) has approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic test for identifying advanced ... Read more
A Phase 3 trial exploring a combination of Seattle Genetics‘ tucatinib plus standard Kadcyla (ado-trastuzumab emtansine) in people with advanced HER2-positive ... Read more
The U.S. label of Nerlynx (neratinib), a treatment for early stage HER2-positive breast cancer, now includes information on the use of two anti-diarrheal ... Read more
Lotus Pharmaceuticals has launched the first generic version of Pierre Fabre’s Navelbine (vinorelbine) in soft capsule form in Europe for the ... Read more
The U.S. Food and Drug Administration (FDA) has approved Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Genentech’s Herceptin (trastuzumab), for all indications ... Read more
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of ... Read more
Breast cancer treatment Nerlynx (neratinib) will be exclusively commercialized in Canada by Knight Therapeutics, under an agreement with the therapy’s developer, Puma Biotechnology. ... Read more
The U.S. Food and Drug Administration (FDA) has rejected Immunomedics’ application for accelerated approval of sacituzumab govitecan as third-line treatment for ... Read more
The Phase 3 trial assessing Athenex‘s Oraxol — an oral formulation of the chemotherapy paclitaxel — for the treatment of advanced breast cancer ... Read more
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