NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…

November 27, 2025

GE HealthCare Reports the FDA Premarket Authorization of Pristina Recon DL for Mammography

Shots: The US FDA has granted PMA to Pristina Recon DL, enabling the integration of deep learning with iterative reconstruction to deliver high-quality digital breast tomosynthesis (DBT) images without increasing patient radiation dose Pristina Recon DL utilizes 2 sequential deep learning models to separate signal from noise, with the first model reconstructing high-fidelity 3D volumes…

November 27, 2025

Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

Shots: The EC has approved Lenivia (Q3W) for the reduction of pain associated with osteoarthritis in dogs Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs Lenivia, a monoclonal antibody targeting NGF, is designed to provide longer-lasting pain relief in osteoarthritis by…

November 27, 2025

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Shots: The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across…

November 26, 2025

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Shots: FDA has approved perioperative Imfinzi for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, with submission reviewed under Project Orbis & based on P-III (MATTERHORN) trial; regulatory review is ongoing in the EU & Japan In the trial, Pts (n=948) received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W ×…

November 26, 2025

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Shots: Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026 Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety Additionally,…

November 26, 2025

Prestige Biopharma Collaborates with Biosidus to Commercialize Tuznue (Biosimilar, Herceptin) Across LATAM

Shots: Prestige Biopharma has entered into an exclusive license & supply agreement with Biosidus to commercialize Tuznue, a biosimilar version of Herceptin (trastuzumab) across Latin American markets, incl. Argentina, Mexico, Bolivia, & Paraguay As per the deal, Biosidus gains exclusive rights to market & distribute Tuznue in Argentina, Mexico, Bolivia & Paraguay, while Prestige Biopharma…

November 26, 2025

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

November 26, 2025

Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

Shots: The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product Ponlimsi & Degevma are anti-RANKL monoclonal…

November 26, 2025

Gilead Acquires TREX1 Program from Sprint Bioscience for ~$414M

Shots: Sprint Bioscience has reported the sale of its TREX1 cancer program to Gilead Sciences As per the Deal, Sprint Bioscience will receive $14M upfront and up to $400M in clinical, regulatory, and commercial milestones TREX1 program has demonstrated notable potential in the pre-clinical stage Ref: Sprint Bioscience | Image: Gilead & Sprint Bioscience | Press…

November 25, 2025

NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

GE HealthCare Reports the FDA Premarket Authorization of Pristina Recon DL for Mammography

Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Prestige Biopharma Collaborates with Biosidus to Commercialize Tuznue (Biosimilar, Herceptin) Across LATAM

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

Gilead Acquires TREX1 Program from Sprint Bioscience for ~$414M

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