NEWS

Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio Designed for short-term recordings up to 2.5hrs., the…

15 minutes ago

Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration

Shots: Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD) The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…

1 hour ago

Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The EC has approved Keytruda/Keytruda SC + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapies, in all 30 EEA member states Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda…

19 hours ago

Biocytogen and Sihuan Pharmaceutical Partner to Discover Novel Therapeutics in Multiple Indications

Shots: Biocytogen has partnered with Sihuan Pharmaceutical to discover innovative therapies across multiple areas, incl. weight loss As per the deal, Biocytogen and Sihuan will combine Biocytogen’s fully human antibody discovery platform with Sihuan’s development, manufacturing, & commercialization capabilities In this collaboration, Biocytogen will leverage its integrated platforms, incl. target-humanized mouse models, in vivo efficacy…

20 hours ago

AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma

Shots: The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…

21 hours ago

Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has received NDA of bezuclastinib under the RTOR program for the treatment of pts with GIST who were previously treated with imatinib, backed by the P-III (PEAK) trial of bezuclastinib + sunitinib vs sunitinib monotx. Trial met its 1EP of improved PFS by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of…

23 hours ago

JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: JenaValve Technology has launched Trilogy THV System to treat ssAR in pts at high or greater surgical risk & reported successful first cases across the US The System uses radiopaque locators to attach directly to native aortic leaflets without calcification, allowing stable implantation, precise alignment, reduced paravalvular regurgitation, & preserving future coronary access with…

1 day ago

Eli Lilly Reports US FDA Approval of Foundayo (Orforglipron) for Weight Loss

Shots: FDA has approved Foundayo along with lifestyle intervention for obese/overweight adults with weight-related medical problems; Foundayo will be available via LillyDirect beginning Apr 6, 2026 Approval was backed by the ATTAIN program, incl. ATTAIN-1, where Foundayo showed weight loss of 27.3 lbs (12.4%) vs 2.2 lbs (0.9%) with PBO at the highest dose, with…

1 day ago

Axsome Therapeutics Acquires Global Rights to Balipodect from Takeda

Shots: Axsome has entered into an asset purchase agreement with Takeda for TAK-063 (balipodect), with an intention to develop it for treating schizophrenia & Tourette syndrome (P-III trial-enabling activities for schizophrenia to begin in 2026) As per the deal, Axsome gains global rights to develop, manufacture, & commercialize TAK-063, while Takeda receives an upfront payment,…

2 days ago

GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma

Shots: The Chinese NMPA has approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) characterised by an eosinophilic phenotype based on P-III (SWIFT-1: n=382) & (SWIFT-2: n=380) trials Exdensur reduced asthma exacerbations by 58% (SWIFT-1) & 48% (SWIFT-2) over 52wks., with results in Chinese pts (n=58, SWIFT-1) consistent with the overall population. Pooled data…