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SynCardia Systems, LLC, a subsidiary of Picard Medical Inc. (NASDAQ:PMI), has reached a defining moment in the advancement of artificial organ technology. The company confirmed the first successful in vivo implantations of its fully implantable Emperor Total Artificial Heart, marking a pivotal milestone in …
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the U.S.Food and Drug Administrationhas approved EYLEA HD (aflibercept injection 8 mg) for adult patients with macular edema following retinal vein occlusion. This approval adds a monthly (every four-week) dosing option across all previously approved indications, including wet …
Amgen (NASDAQ:AMGN) has received full approval from the U.S.Food and Drug Administrationfor IMDELLTRA (tarlatamab-dlle), a targeted therapy for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. This decision upgrades IMDELLTRA’s initial accelerated approval, marking a …
Gilead Sciences, Inc. (Nasdaq:GILD) has taken a crucial step in global HIV prevention with the first deliveries of its twice-yearly injectable PrEP medicine, lenacapavir, to Eswatini and Zambia. These shipments signify an important moment for communities in sub-Saharan Africa, a region that accounts for …
Zymeworks Inc. (Nasdaq:ZYME) has launched a strategic initiative designed to maximize long-term value from its growing roster of licensed biotherapeutics and healthcare assets. This decision follows encouraging developments across key programs, including positive topline data from the pivotal Phase 3 HERIZON-GEA-01 trial for Ziihera …
Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) has achieved a major regulatory milestone as the U.S.Food and Drug Administration approvedREDEMPLO (plozasiran) for the treatment of adult patients with familial chylomicronemia syndrome. This marks the company’s first FDA-approved medicine and represents a pivotal step in its evolution from …
Genmab A/S (NASDAQ:GMAB) has received a major regulatory milestone with the U.S.Food and Drug Administrationgranting approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide, collectively known as EPKINLY + R2, for adults with relapsed or refractory follicular lymphoma. This approval introduces the first-ever …
Olema Pharmaceuticals (NASDAQ:OLMA) gained significant market attention after Roche Holding AG (OTC:RHHBY) unveiled promising findings from its phase 3 lidERA trial evaluating giredestrant, an investigational oral selective estrogen receptor degrader, in patients with early-stage ER+/HER2- breast cancer. The large-scale study included more than 4,100 …
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) announced encouraging topline results from its randomized, double-blind, placebo-controlled study evaluating tradipitant for preventing nausea and vomiting triggered by GLP-1 receptor agonist therapy. The study examined adults who were overweight or obese and had no prior GLP-1 agonist exposure.Participants were …
Incyte(NASDAQ:INCY) has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval ofMinjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma after at least one …
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