NEWS

Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

Shots: The UK’s MHRA has approved Oczyesa (octreotide SC depot) for the maintenance treatment in adult with acromegaly who have responded to & tolerated somatostatin analogs, following EC approval on Jun 30, 2025; UK launch expected in Q4’25 Approval was based on extensive data from 7 trials, incl. 4 P-I trials, 1 P-II trials &…

August 29, 2025

ExCellThera Reports the EC’s Conditional Approval of Zemcelpro for Haematological Malignancies

Shots: The EC has granted conditional approval to Zemcelpro in all 30 EEA states for adults with haematological malignancies needing ASCT after myeloablative conditioning, when no other suitable donor cells are available; regulatory filing is underway in the US, UK, Canada & Switzerland Zemcelpro availability will vary by country based on national reimbursement processes; meanwhile,…

August 29, 2025

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

Shots: BioPorto has reported the US launch of the ProNephro acute kidney injury (AKI) test through its collaboration with Roche, following its FDA 510(k) clearance on Roche’s cobas c 501 analyzers for hospital clinical laboratories ProNephro AKI (NGAL) is an AKI biomarker test for pediatric use (3mos.–21yrs.), which helps identifying ICU pts at risk of…

August 28, 2025

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

Shots: Health Canada has approved Rinvoq (15mg; QD) as a monotx. & in combination with corticosteroid to treat adults with giant cell arteritis (GCA) Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…

August 28, 2025

Eli Lilly Reports Topline P-III (monarchE) Trial Data of Verzenio (Abemaciclib) to Treat Early Breast Cancer

Shots: Eli Lilly has reported topline P-III (monarchE) trial data assessing Verzenio (150mg, BID) + SoC adj. ET vs SoC adj. ET in 2 cohorts (N=5,637) for pts with HR+, HER2-, node-positive early breast cancer at high risk of recurrence Cohort 1 (n=5,120; FDA-approved) incl. pts with ≥4 positive nodes or 1–3 nodes plus tumor ≥5…

August 28, 2025

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Shots: Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA…

August 28, 2025

Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…

August 28, 2025

Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

Shots: FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data…

August 28, 2025

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Shots: The EC has approved neoadj. Tevimbra + Pt-based CT followed by adj. Tevimbra monotx. for adults with resectable NSCLC at high risk of recurrence Approval was based on P-III (RATIONALE-315) trial assessing perioperative Tevimbra with CT before surgery vs PBO + CT in NSCLC pts (n=453), which met its dual 1EPs of EFS &…

August 27, 2025

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Shots: The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regions NDA was supported by the QUANTI clinical program, which incl.…

August 27, 2025

NEWS

Camurus Receives the MHRA’s Approval for Oczyesa as Maintenance Treatment of Acromegaly

ExCellThera Reports the EC’s Conditional Approval of Zemcelpro for Haematological Malignancies

BioPorto Launches ProNephro AKI (NGAL) to Detect Acute Kidney Injury in the US

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

Eli Lilly Reports Topline P-III (monarchE) Trial Data of Verzenio (Abemaciclib) to Treat Early Breast Cancer

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

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