Merck and the European Thoracic Oncology Platform (ETOP) recently announced that Keytruda significantly improved disease-free survival (DFS) in patients with stage IB to IIA non-small cell lung cancer...
Boehringer Ingelheim recently announced that the Phase 3 clinical trial studying empagliflozin in adults with chronic kidney disease (CKD) will stop early based on a recommendation from the trial's...
Pfizer recently announced that a Clostridioides difficile (C. difficile) vaccine candidate did not meet its primary endpoint of C. difficile infection (CDI) prevention, but was 100- percent effective...
Pfizer recently initiated a Phase 2/3 clinical trial to evaluate the safety, pharmacokinetics, and efficacy of its COVID-19 treatment, Paxlovid, in non-hospitalized, symptomatic pediatric...
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...
Gilead recently announced that the Phase 3 clinical trial of Trodelvy in patients with HR/HER2-metastatic breast cancer met its primary endpoint.
The Phase 3 TROPiCS-02 study evaluated Trodelvy versus...
FDA recently issued three final guidance documents to the industry regarding cancer clinical trials that parallel the goals of President Biden’s effort to renew and rebuild upon his 2016 Cancer...
FDA recently issued a complete response letter (CRL) to Gilead rejecting its New Drug Application (NDA) for HIV-1 treatment, lenacapavir.
The agency cited Chemistry Manufacturing and Controls (CMC)...
FDA recently accepted Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for its non-small cell lung cancer (NSCLC) drug, Opdivo, plus chemotherapy.
The agency based its...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently adopted a positive opinion for Pfizer and Biohaven’s generic drug to treat migraine...
The CDC Advisory Committee on Immunization Practices (ACIP) recently recommended Pfizer’s tick-borne encephalitis (TBE) vaccine, TicoVac, to prevent TBE in individuals one year and older.
ACIP...
GSK and Sanofi recently announced that they will submit data from their Phase 3 efficacy and booster trials for regulatory approval of their COVID-19 vaccine.
The Phase 3 VAT08 efficacy study...
Gilead recently announced one-year results from an ongoing Phase 2/3 CAPELLA trial evaluating its HIV-1 capsid inhibitor, lenacapavir, in individuals with multi-drug resistant HIV.
The trial...
Patient factors, including Medicaid or Medicare Advantage, comorbid substance use disorder, medical comorbidities, and prescription-related factors, are associated with opioid overdose, according to a...
Convalescent plasma from patients who have recovered from COVID-19 reduced hospitalizations by nearly 50% for outpatients infected with the virus in a nationwide, multicenter clinical trial.
Johns...
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...
Johnson & Johnson recently announced that its COVID-19 vaccine, Ad26.COV2.S, was 85 percent effective against coronavirus-related hospitalization in a Phase 3b study.
The South African Medical...
FDA recently granted emergency use authorization to Roche’s COVID-19 At-Home Test for children aged 14 years and older and by an adult for children aged two to 13 years.
The COVID-19 At-Home...
FDA recently issued an emergency use authorization for Merck’s COVID-19 treatment, molnupiravir, for adults 18 years of age and older.
The agency authorized the treatment for adults with high...
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...
