FDA Updates Articles
The U.S. Food and Drug Administration has approved Celltrion’s Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson’s Remicade drug used to treat autoimmune diseases.
The U.S. Food and Drug Administration has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAFV600 wildtype and BRAFV600 mutation-positive unresectable or metastatic melanoma.
The U.S. Food and DrugAdministration approved Merck and Co.’s Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuroniumbromide and vecuronium bromide.
The U.S. Food and Drug Administration granted accelerated approval for pembrolizumab (Keytruda, Merck & Co.) for treatment of patients with advanced (metastatic)
non-small cell lung cancer.
The U.S. Food and Drug Administration has approved Baxalta’s Adynovate for use in hemophilia A patients aged 12 years and older.
The U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus or have had a confirmed Zika virus infection.
The U.S. Food and Drug Administration has approved Fluad (Seqirus), an influenza vaccine that contains the adjuvant MF59.
The U.S. Food and Drug Administration ha approved Octapharma’s NUWIQ, antihemophilic factor (recombinant), an intravenous therapy for adults and children living with hemophilia A.
The U.S. Food and Drug Administration has approved Belbuca (buprenorphine) buccal film for patients with severe chronic pain.
The U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of advanced melanoma.
Hailed as a major advancement in the fight against skin cancer, the U.S. Food and Drug Administration (FDA) has approved a new immune-based therapy for treating metastatic melanoma.
