Pharma Globenewswire

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

28 November 2025

The multiple myeloma therapeutic landscape has undergone a significant transformation with the FDA’s approval of Johnson & Johnson (NYSE:JNJ)’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). This regulatory milestone, announced

Drug Launches & Approvals

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

28 November 2025

The pharmaceutical landscape for neurofibromatosis type 1 (NF1) treatment has reached a significant turning point with the FDA’s approval of KOSELUGO (selumetinib, AstraZeneca Pharmaceuticals LP) on November 19, 2025, for adults with NF1 who have symptomatic, inoperable plexiform neurofibromas (PN).

FDA Approves Amgen’s IMDELLTRA (Tarlatamab-dlle): A Breakthrough in Extensive Stage Small Cell Lung Cancer Treatment

The pharmaceutical landscape for extensive stage small cell lung cancer (ES-SCLC) treatment has reached a

FDA Approves Merck’s KEYTRUDA and KEYTRUDA QLEX in Combination with Astellas Pharma’s PADCEV as Perioperative Treatment for Muscle-Invasive Bladder Cancer

The muscle-invasive bladder cancer (MIBC) treatment landscape has undergone a transformation with the FDA’s approval

Maket Insights

Market Insights

EGFR Inhibitor Market Expected to Gain Momentum Through 2034 | DelveInsight

19 November 2025

DelveInsight’s “EGFR Inhibitor Market Insights, Epidemiology, and Market Forecast-2034” report provides an in-depth analysis of the EGFR Inhibitor market, including historical and projected epidemiology

Market Insights

Myelofibrosis Market Poised to Expand Significantly at 9% CAGR from 2025 to 2034 | DelveInsight

19 November 2025

The introduction of novel therapies, including BESREMi (PharmaEssentia/AOP Orphan Pharmaceuticals), INCB057643 (Incyte), XPOVIO (Karyopharm Therapeutics), RYTELO (Geron), REBLOZYL (Bristol Myers Squibb), Navtemadlin (Kartos Therapeutics),

Market Insights

KRAS Inhibitors Market Set for Breakneck 35% CAGR Growth by 2034 | DelveInsight

19 November 2025

The KRAS inhibitors market is projected to witness strong expansion, fueled by the growing burden of cancer, wider access to advanced therapies, and a

Market Insights

Niemann-Pick Type C Market Poised for Strong 14.8% CAGR Growth (2025–2034) | DelveInsight

19 November 2025

The NPC market remains constrained by the scarcity of approved therapies and a substantial unmet medical need. Nonetheless, upcoming treatments, including Cyclo Therapeutics’ Trappsol

Market Insights

Triple-Negative Breast Cancer Market to Showcase Growth at 4.7% CAGR Through 2034 | DelveInsight

19 November 2025

The TNBC market is projected to expand, driven by rising disease prevalence, advances in targeted treatment options, and the introduction of new therapies, including

News

News

Androgen Receptor Targeted Therapies Market Outlook: Key Trends and Growth Forecast Across the 7MM (2025-2034) | DelveInsight

20 November 2025

The androgen receptor–targeted therapies market is expected to experience significant growth in the coming years. This expansion is fueled by an increasing incidence of cancers, heightened awareness of these therapies, and a robust pipeline of androgen receptor–targeted treatments currently under clinical investigation and pending regulatory approval from various companies. DelveInsight’s report provides a comprehensive understanding of current treatment practices and

News

NCFB Market on the Brink of Change as First DPP1 Inhibitor Marks Approval | DelveInsight

19 November 2025

The NCFB market is entering a new phase as Insmed’s BRINSUPRI has

Market Insights

Triple-Negative Breast Cancer Market to Showcase Growth at 4.7% CAGR Through 2034 | DelveInsight

19 November 2025

The TNBC market is projected to expand, driven by rising disease prevalence, advances in targeted treatment

News

NCFB Market on the Brink of Change as First DPP1 Inhibitor Marks Approval | DelveInsight

19 November 2025

The NCFB market is entering a new phase as Insmed’s BRINSUPRI has achieved a major regulatory

Market Insights

Niemann-Pick Type C Market Poised for Strong 14.8% CAGR Growth (2025–2034) | DelveInsight

19 November 2025

The NPC market remains constrained by the scarcity of approved therapies and a substantial unmet medical

Market Insights

KRAS Inhibitors Market Set for Breakneck 35% CAGR Growth by 2034 | DelveInsight

19 November 2025

The KRAS inhibitors market is projected to witness strong expansion, fueled by the growing burden of

Market Insights

Myelofibrosis Market Poised to Expand Significantly at 9% CAGR from 2025 to 2034 | DelveInsight

19 November 2025

The introduction of novel therapies, including BESREMi (PharmaEssentia/AOP Orphan Pharmaceuticals), INCB057643 (Incyte), XPOVIO (Karyopharm Therapeutics), RYTELO

Latest

Drug Launches & Approvals

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

28 November 2025

Drug Launches & Approvals

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

28 November 2025

Drug Launches & Approvals

FDA Approves Amgen’s IMDELLTRA (Tarlatamab-dlle): A Breakthrough in Extensive Stage Small Cell Lung Cancer Treatment

28 November 2025

The pharmaceutical landscape for extensive stage small cell lung cancer (ES-SCLC) treatment has reached a significant inflection point with the FDA’s traditional approval of IMDELLTRA (tarlatamab-dlle) on November 19, 2025, for adults with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Drug Launches & Approvals

FDA Approves Merck’s KEYTRUDA and KEYTRUDA QLEX in Combination with Astellas Pharma’s PADCEV as Perioperative Treatment for Muscle-Invasive Bladder Cancer

28 November 2025

The muscle-invasive bladder cancer (MIBC) treatment landscape has undergone a transformation with the FDA’s approval of KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Astellas Pharma’ PADCEV (enfortumab vedotin-ejfv), as perioperative treatment for adult patients with MIBC

Drug Launches & Approvals

Novartis Receives FDA Approval for ITVISMA Gene Replacement Therapy in Spinal Muscular Atrophy

28 November 2025

Novartis received the FDA approval for ITVISMA (onasemnogene abeparvovec-brve) on 24th November 2025, marking a significant milestone for patients living with spinal muscular atrophy (SMA) and the broader neurological disease. This regulatory decision establishes ITVISMA as the first and only gene replacement

Drug Launches & Approvals

FDA Approves AstraZeneca’s Durvalumab (IMFINZI): A Paradigm Shift in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma Treatment

27 November 2025

The therapeutic landscape for resectable gastric and gastroesophageal junction adenocarcinoma (GC/GEJC) has undergone a significant transformation with the FDA’s approval of durvalumab (AstraZeneca) on November 25, 2025, for use in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and

Drug Launches & Approvals

FDA Approves Otsuka’s VOYXACT (Sibeprenlimab-szsi): A Breakthrough in Primary Immunoglobulin A Nephropathy Treatment

27 November 2025

The pharmaceutical landscape for immunoglobulin A nephropathy (IgAN) treatment has reached a significant inflection point with the FDA’s accelerated approval of VOYXACT (sibeprenlimab-szsi) on November 25, 2025, for the reduction of proteinuria in adults with primary IgAN at risk for disease progression.

Uncategorised

Global AI in Medical Diagnostics Market Set for Exceptional Growth at a CAGR of ~22% by 2032 | DelveInsight

20 November 2025

The global artificial intelligence (AI) in medical diagnostics market is expanding at a rapid pace, driven by the rising incidence of chronic, genetic, and infectious diseases. AI-powered diagnostic solutions enable earlier detection, more accurate diagnoses, and personalized treatment planning by analyzing complex

Uncategorised

Global Oxygen Therapy Equipment Market Expected to Grow at ~8% CAGR by 2032 Driven by Increasing Respiratory Disorders and Technological Advancements | DelveInsight

20 November 2025

The global oxygen therapy equipment market is witnessing substantial growth, fueled by the rising prevalence of respiratory disorders, increasing use in critical care settings, and rapid technological advancements. The growing incidence of chronic lung diseases such as COPD and asthma has heightened

1 2 3 4 Next

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

FDA Approves Amgen’s IMDELLTRA (Tarlatamab-dlle): A Breakthrough in Extensive Stage Small Cell Lung Cancer Treatment

FDA Approves Merck’s KEYTRUDA and KEYTRUDA QLEX in Combination with Astellas Pharma’s PADCEV as Perioperative Treatment for Muscle-Invasive Bladder Cancer

Maket Insights

EGFR Inhibitor Market Expected to Gain Momentum Through 2034 | DelveInsight

Myelofibrosis Market Poised to Expand Significantly at 9% CAGR from 2025 to 2034 | DelveInsight

KRAS Inhibitors Market Set for Breakneck 35% CAGR Growth by 2034 | DelveInsight

Niemann-Pick Type C Market Poised for Strong 14.8% CAGR Growth (2025–2034) | DelveInsight

Triple-Negative Breast Cancer Market to Showcase Growth at 4.7% CAGR Through 2034 | DelveInsight

News

Androgen Receptor Targeted Therapies Market Outlook: Key Trends and Growth Forecast Across the 7MM (2025-2034) | DelveInsight

NCFB Market on the Brink of Change as First DPP1 Inhibitor Marks Approval | DelveInsight

Clinical Trials

Triple-Negative Breast Cancer Market to Showcase Growth at 4.7% CAGR Through 2034 | DelveInsight

NCFB Market on the Brink of Change as First DPP1 Inhibitor Marks Approval | DelveInsight

Niemann-Pick Type C Market Poised for Strong 14.8% CAGR Growth (2025–2034) | DelveInsight

KRAS Inhibitors Market Set for Breakneck 35% CAGR Growth by 2034 | DelveInsight

Myelofibrosis Market Poised to Expand Significantly at 9% CAGR from 2025 to 2034 | DelveInsight

Latest

FDA Approves Johnson & Johnson’s DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma: Advancing Early Multiple Myeloma Intervention

FDA Approves AstraZeneca’s KOSELUGO (Selumetinib) for Adults with Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas

FDA Approves Amgen’s IMDELLTRA (Tarlatamab-dlle): A Breakthrough in Extensive Stage Small Cell Lung Cancer Treatment

FDA Approves Merck’s KEYTRUDA and KEYTRUDA QLEX in Combination with Astellas Pharma’s PADCEV as Perioperative Treatment for Muscle-Invasive Bladder Cancer

Novartis Receives FDA Approval for ITVISMA Gene Replacement Therapy in Spinal Muscular Atrophy

FDA Approves AstraZeneca’s Durvalumab (IMFINZI): A Paradigm Shift in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma Treatment

FDA Approves Otsuka’s VOYXACT (Sibeprenlimab-szsi): A Breakthrough in Primary Immunoglobulin A Nephropathy Treatment

Global AI in Medical Diagnostics Market Set for Exceptional Growth at a CAGR of ~22% by 2032 | DelveInsight

Global Oxygen Therapy Equipment Market Expected to Grow at ~8% CAGR by 2032 Driven by Increasing Respiratory Disorders and Technological Advancements | DelveInsight

Recent Posts

Recent Comments

Hi There!

Banner

Latest Interviews

Newsletter

Authors