FDA recently lifted the clinical hold on Gilead’s investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis...
Bristol Myers Squibb recently announced that its severe plaque psoriasis treatment, deucravacitinib, elicited durable efficacy and a consistent safety profile in adult...
Pfizer recently announced that its COVID-19 treatment, Paxlovid reduced disease by 32% and 37% in adults for 5–10 days, respectively, compared to placebo.
The Phase 2/3 EPIC-PEP study...
Bristol Myers Squibb and Nektar Therapeutics recently ended the global clinical development program for their combination drug therapy, bempegaldesleukin (BEMPEG) and Opdivo (nivolumab), in renal cell...
Novartis recently announced that its IgG4 anti-PD-1 monoclonal antibody, tislelizumab, plus chemotherapy, significantly improved overall survival (OS) compared to chemotherapy in esophageal...
Gilead and Dragonfly Therapeutics recently collaborated to advance several of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation...
Eli Lilly and Company recently announced that patients in a Phase 3 trial who received its obesity drug, tirzepatide, lost up to 22.5% of their body weight.
The SURMOUNT-1 clinical trial...
Roche recently announced new three-year data of its study evaluating Evrysdi (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA).
The FIREFISH study evaluated the...
FDA recently approved AstraZeneca’s Ultomiris to treat adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
The agency based the...
FDA recently accepted AstraZeneca’s biologics license application (BLA) for its anti-CTLA4 antibody, tremelimumab, supporting the indication of a single primary dose of the drug added to Imfinzi...
Sandoz recently launched its generic drug combination eyedrop, brimonidine tartrate/ timolol maleate ophthalmic solution 0.2%/0.5%, to lower eye pressure in patients with ocular...
FDA recently accepted the New Drug Application (NDA) for GSK’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat patients with anemia of chronic kidney...
Today, the FDA is proposing a total ban on flavored cigarettes and cigars, citing their link to increased rates of addiction in young people and their elevated risk of enhanced effects on the...
FDA recently issued an emergency use authorization (EUA) for the first COVID-19 test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.
Qualified,...
The FDA recently granted priority review for AstraZeneca's Enhertu to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and...
Sanofi recently announced positive results from the Phase 1/2 clinical trial evaluating its Bruton's tyrosine kinase (BTK) inhibitor, rilzabrutinib, in adults with heavily pre-treated immune...
FDA recently lifted the partial hold placed on clinical trials evaluating Gilead’s magrolimab combined with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)...
Moderna recently dosed the first patients in a Phase 1/2 study of its influenza mRNA vaccine candidates, mRNA-1020 and mRNA-1030.
The randomized, observer-blind trial will evaluate the safety,...
Sanofi recently launched its first-in-pharma Diversity, Equity, & Inclusion (DE&I) Board to encourage an inclusive and diverse culture that enables breakthrough innovations.
The...
FDA recently issued draft guidance to enroll more participants from underrepresented racial and ethnic populations in the United States into trials, expanding overall clinical trial...
