Approvals
The U.S. FDA granted Amgen Priority Review for sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), after at least one previous systemic therapy.
The U.S. Food and Drug Administration (FDA) approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy.
The U.S. Food and Drug Administration (FDA) has several solid PDUFA dates in the middle of February. Here’s a look.
The U.S. FDA approved Regeneron’s monoclonal antibody Evkeeza (evinacumab-dgnb) as an add-on treatment for adult and pediatric patients ages 12 and above with homozygous familial hypercholesterolemia (HoFH).
The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Bristol Myers picked up the therapy when it acquired Celgene in 2019 for $74 billion.
It was a busy week for clinical trial updates. Here’s a look.
Johnson & Johnson’s Janssen Biotech submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its single-dose COVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration.
PRESS RELEASES