Eli Lilly & Company recently announced updates on the Phase 2 clinical trial studying its kinase inhibitor, Retevmo, in RET fusion-positive non-small cell lung cancer (NSCLC).
The...
FDA recently approved ViiV Healthcare’s fixed-dose combination of abacavir, dolutegravir, and lamivudine to treat pediatric patients with HIV-1.
The agency also approved the...
Merck recently reaffirmed its commitment to enable broad equitable access to its human papillomavirus (HPV) vaccines.
Under the initiative, Merck will expand its vaccines manufacturing facility...
FDA recently expanded the indication of the long-acting injectable HIV regimen, Cabenuva, to include virologically suppressed adolescents 12 years of age and older.
Johnson & Johnson and...
FDA recently approved Bristol Myers Squibb’s antibody combination, Opdualag (nivolumab and relatimab-rmbw), for adult and pediatric patients 12 years of age and older with unresectable or...
FDA recently approved Boehringer Ingelheim's Jardiance to reduce the risk of cardiovascular death and hospitalization in heart failure in adults.
The agency based its approval on the safety and...
US Food and Drug Administration approval processes comprise numerous steps to ensure the safety and efficacy of new drugs, therapies, and treatments. Navigating the process can be complex and time-consuming, and as a result, the FDA is...
ViiV Healthcare, GSK, and Shionogi recently entered a $1.25-billion settlement over the global patent infringement litigation with Gilead concerning its HIV drug combined with three HIV integrase...
FDA recently approved Takeda Pharmaceutical’sPharmaceutical’s Vonvendi for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand...
FDA recently approved an update to the prescribing information for Kite’s Yescarta to include prophylactic corticosteroids across all approved indications.
The agency first approved Yescarta in...
FDA fully approves Moderna’s mRNA COVID-19 vaccine, Spikevax, for individuals 18 years of age and older.
"The full licensure of Spikevax in the US now joins that in Canada, Japan, the European...
FDA recently approved new expanded magnetic resonance imaging (MRI) compatibility for Abbott’s Proclaim XR Spinal Cord Stimulation (SCS) System with Octrode Leads.
The Proclaim XR SCS System is...
FDA recently approved two pediatric indications for Johnson & Johnson’s direct oral anticoagulant (DOAC), Xarelto.
The agency approved the drug to treat venous thromboembolism (VTE) and to...
FDA recently approved ViiV Healthcare’s long-acting injectable pre-exposure prophylaxis (PrEP) treatment, Apretude, to reduce the risk of sexually acquired HIV-1.
The agency approved Apretude...
FDA recently approved Pfizer’s Xeljanz (tofacitinib) to treat adults with active ankylosing spondylitis (AS).
The agency approved the drug specifically for individuals who have had an inadequate...
FDA recently approved imaging drug Cytalux to assist surgeons in identifying ovarian cancer lesions.
Cytalux is approved for use in adult patients with ovarian cancer to help identify...
FDA recently approved Voxzogo injection for children five years of age and older with achondroplasia and open epiphyses.
Achondroplasia is the most common form of dwarfism. Individuals living...
FDA recently approved Novartis’ Scemblix to treat chronic myeloid leukemia (CML) for adult and pediatric patients with Philadelphia chromosome-positive CML in chronic phase.
Scemblix is the...
FDA recently approved a new low-dose tablet dosage form of Gilead’s HIV-1 drug, Biktarvy, in pediatric patients.
The agency approved the new dosage for children weighing at least 30 pounds who...
FDA recently approved Boehringer Ingelheim’s Cyltezo as the first interchangeable biosimilar product to treat certain inflammatory diseases.
Specifically, the agency approved the drug for...
