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 +…

ByRidhi RastogiAugust 28, 2025

NEWS

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…

ByRidhi RastogiAugust 28, 2025

NEWS

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…

ByRidhi RastogiAugust 28, 2025

NEWS

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…

ByRidhi RastogiAugust 28, 2025

NEWS

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…

ByRidhi RastogiAugust 28, 2025

NEWS

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 &…

ByRidhi RastogiAugust 27, 2025

NEWS

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.…

ByRidhi RastogiAugust 27, 2025

NEWS

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Shots: Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty in pts (n >260) with PAD BTK, which showed sustained efficacy & ability to open vessels…

ByRidhi RastogiAugust 27, 2025

NEWS

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions Trial met its 1EP of improved MG-ADL total score, showing…

ByRidhi RastogiAugust 27, 2025

NEWS

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while PURPOSE 2 depicted 99.9% non-infection rate in 2179 pts (2 acquired HIV), showing superiority to bHIV in both trials; published in The NEJM Approval is…

ByRidhi RastogiAugust 27, 2025

Ridhi Rastogi

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

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

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