AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer

Shots: The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an option Trial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data to be presented in a future meeting &…

ByRidhi Rastogi18 hours ago

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s sBLA Acceptance of Enhertu Regimen for HER2+ Breast Cancer

Shots: FDA has accepted an sBLA of neoadj. Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) for the treatment of adults with HER2+ (IHC 3+ or ISH+) stage 2/3 breast cancer (PDUFA: May 18, 2026) sBLA was backed by the P-III (DESTINY-Breast11) trial assessing neoadj. Enhertu alone (5.4mg/kg) ± THP vs ddAC + THP in…

ByRidhi Rastogi4 days ago

NEWS

Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults

Shots: Amgen has reported the global P-III (VESALIUS-CV) trial findings assessing Repatha vs PBO, both in addition to optimized lipid-lowering therapy in adults (n >12,000) at high CV risk without prior heart attack or stroke At an mFU of 4.5yrs., the trial met its co-1EPs of time to first occurrence of composite of coronary heart…

ByRidhi Rastogi4 days ago

NEWS

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Shots: The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…

ByRidhi Rastogi4 days ago

NEWS

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…

ByRidhi RastogiOctober 1, 2025

NEWS

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in China Approval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…

ByRidhi RastogiOctober 1, 2025

NEWS

Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025

Shots: The P-III (HYPERION) trial assessed Winrevair vs PBO, both with background therapy in recently diagnosed adults (n=320) with PAH (WHO Group 1) FC II or III at intermediate or high risk of disease progression Trial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in…

ByRidhi RastogiSeptember 30, 2025

NEWS

Health Hope Pharma Collaborates with Gilead Sciences to Advance Encequidar in Virology

Shots: Health Hope Pharma (HHP) has entered into a global licensing & collaboration agreement with Gilead Sciences to advance encequidar in the field of virology As per the deal, Gilead will receive exclusive global virology rights to encequidar, while HHP & Hanmi Pharm will provide drug supply, technical support, project collaboration & receive an upfront…

ByRidhi RastogiSeptember 30, 2025

NEWS

Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC

Shots: The P-III (METIS) trial assessed TTFields therapy + best supportive care (BSC) (n=149) vs BSC (n=149) in 298 adults with 1-10 newly diagnosed brain metastases from NSCLC following stereotactic radiosurgery; median TTFields use was 67% over 16wks. Trial met its 1EP, with a 28% lower risk of intracranial progression, extending median time to 15…

ByRidhi RastogiSeptember 30, 2025

NEWS

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Shots: FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s label Plaque PsO approval was based…

ByRidhi RastogiSeptember 30, 2025

AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer

Daiichi Sankyo and AstraZeneca Report the US FDA’s sBLA Acceptance of Enhertu Regimen for HER2+ Breast Cancer

Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025

Health Hope Pharma Collaborates with Gilead Sciences to Advance Encequidar in Virology

Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

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