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LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Shots: The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which…

ByRidhi Rastogi2 days ago0Comments

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Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk.…

ByRidhi Rastogi2 days ago0Comments

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Kling Bio Joins Forces with Sanofi to Identify Neutralizing Antibodies

Shots: Kling Bio has entered into a collaboration & license option agreement with Sanofi to discover antibodies & epitopes leveraging Kling Bio’s Kling-Select platform Collaboration aims to discover & characterize monoclonal antibodies with strong neutralizing activity against human viral pathogen to allow development of novel antiviral therapies Kling-Select is a validated B cell immortalization platform…

ByRidhi Rastogi2 days ago0Comments

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AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

Shots: AstraZeneca has reported P-III (PREVAIL) trial assessing gefurulimab vs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE study Trial met its 1EP & all 2EPs, showing significant improvement in MG-ADL total score from baseline at 26wks. in adults with AChR…

ByRidhi Rastogi2 days ago0Comments

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GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…

ByDipanshu Dixit2 days ago0Comments

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Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Shots: The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM) Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390) At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive…

ByRidhi Rastogi2 days ago0Comments

VIEWPOINTS

Zai Lab at ASCO 2025: Rafael G. Amado in an Illuminating Dialogue Exchange with PharmaShots

Shots: Recently, Zai Lab presented data from a Phase Ia/Ib study evaluating ZL‑1310, a DLL3 ADC, in patients with extensive‑stage small cell lung cancer, both as a monotherapy and in combination with atezolizumab ZL‑1310 leverages TMALIN technology, enabling clinicians to deliver more targeted doses of chemotherapy to cancer cells, distinguishing the compound from current standard‑of‑care…

BySaurabh Chaubey3 days ago0Comments

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LIFE SCIENCES | DAILY NEWS | JUL 23, 2025 | PHARMASHOTS

ByTushar Maurya3 days ago0Comments

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Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

ByRidhi Rastogi3 days ago0Comments

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Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Shots: The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCT Approval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…

ByRidhi Rastogi3 days ago0Comments

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Kling Bio Joins Forces with Sanofi to Identify Neutralizing Antibodies

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

GSK Receives Health Canada’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

Zai Lab at ASCO 2025: Rafael G. Amado in an Illuminating Dialogue Exchange with PharmaShots

LIFE SCIENCES | DAILY NEWS | JUL 23, 2025 | PHARMASHOTS

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

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