argenx Receives FDA Approval for VYVGART® Hytrulo with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy Today, Halozyme announced that the U.S. Food and Drug Administration (FDA) has approved argenx’s VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment…
Today, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab. This targeted treatment is for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC),…
FDA Approves SKYRIZI® for Ulcerative Colitis, Expanding AbbVie’s IBD Portfolio AbbVie announced that the U.S. FDA has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This marks SKYRIZI as the first IL-23 specific inhibitor approved for…
Marinus Pharmaceuticals, a company focused on developing innovative therapeutics for seizure disorders, has announced topline results from the Phase 3 RAISE trial (NCT04391569). This double-blind, randomized, placebo-controlled study assessed the safety and efficacy of intravenous (IV) ganaxolone for treating refractory…
Celltrion Unveils Positive Phase III Results of CT-P47 Biosimilar for Rheumatoid Arthritis at EULAR 2024 Celltrion has revealed encouraging findings from its Phase III study of CT-P47, a biosimilar referencing RoActemra® (tocilizumab), presented at the Annual European Congress of Rheumatology…
Celltrion today presented positive Phase III data for CT-P47, a biosimilar referencing RoActemra® in patients with moderate-to-severe rheumatoid arthritis (RA), at the Annual European Congress of Rheumatology (EULAR) 2024. The trial demonstrated that CT-P47 has equivalent efficacy and comparable safety…
BeiGene Presents New Data on BRUKINSA® and Venetoclax Combination for High-Risk CLL/SLL at EHA2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib) at…
Sparrow Pharmaceuticals presented data from an ongoing Phase 2 trial of the HSD-1 inhibitor clofutriben (SPI-62) and prednisolone for polymyalgia rheumatica (PMR) at EULAR 2024 in Vienna, Austria (June 12-15). The data suggest that HSD-1 inhibition can enable effective glucocorticoid…
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Augtyro™ (repotrectinib) for treating adult and pediatric patients (12 years and older) with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This includes locally…
Today, the U.S. Food and Drug Administration (FDA) approved BLINCYTO® (blinatumomab) for treating adult and pediatric patients (one month or older) with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease…
AstraZeneca’s Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration (FDA) to enhance glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. This approval follows positive results from the pediatric T2NOW Phase…
Roche announced that the U.S. FDA has granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This automated multiplex real-time PCR assay on the cobas® liat system delivers results in just 20…