Pharmaceutical News
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FDA Approves MannKind’s Afrezza Expanding Needle-Free Mealtime Insulin Access for Children
MannKind’s Afrezza has received FDA approval for use in children and adolescents aged 6 and older with type 1 or type 2 diabetes, marking it as the first inhaled mealtime insulin for this age group in the U.S. This approval offers a needle-free option, enhancing treatment flexibility for young patients managing diabetes. Read more
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FDA Priority Review Puts Roche’s Giredestrant on Track to Transform Early Breast Cancer
The FDA has accepted Roche’s New Drug Application for giredestrant, an oral selective estrogen receptor degrader, as a priority review for treating ER-positive, HER2-negative stage I-III breast cancer. Results from the Phase III lidERA study indicate a 30% reduction in recurrence risk compared to standard therapy. Approval could set a new standard in treatment. Read more
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Moderna and CEPI Collaborate to Develop Ebolavirus Vaccine
Moderna has expanded its collaboration with CEPI to develop a vaccine against Bundibugyo ebolavirus, with CEPI providing up to $50 million for preclinical and Phase I evaluations. The partnership aims to accelerate vaccine development amid an ongoing outbreak, utilizing Moderna’s mRNA platform similar to COVID-19 vaccine efforts. Read more
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European Commission Approves Amgen’s IMDYLLTRA Following 40% Survival Advantage in SCLC
Amgen’s IMDYLLTRA (tarlatamab) has gained European Commission approval as a monotherapy for adults with extensive-stage small cell lung cancer after chemotherapy failure. This bispecific T-cell engager, targeting DLL3, demonstrated a 40% reduction in death risk and improved overall survival, offering a significant advancement in treatment options for this aggressive cancer. Read more
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ASCO Data Show Novartis’ Scemblix Sustains Long-Term Efficacy in Chronic Myeloid Leukemia
At the 2026 ASCO Annual Meeting, Novartis presented long-term data showing that Scemblix (asciminib) maintains superior efficacy and a favorable safety profile through Week 144 in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia. Results from the ASC4FIRST trial indicate continued improvements in major molecular response rates compared to traditional TKIs. Read more
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Pfizer’s Braftovi Regimen Nearly Doubles Progression-Free Survival in Metastatic Colorectal Cancer
Pfizer’s Braftovi-based regimen significantly improved outcomes in previously untreated BRAF V600E-mutant metastatic colorectal cancer, nearly doubling median progression-free survival to 15.2 months. The treatment reduced disease progression risk by 56% and overall survival risk by 44%. These findings highlight the potential of targeted therapies in addressing this aggressive cancer subtype. Read more
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Incyte’s Tafasitamab Shows Improved Outcomes in DLBCL at ASCO
Incyte’s Phase III frontMIND study revealed that the combination of tafasitamab, lenalidomide, and R-CHOP significantly improved progression-free survival in high-risk diffuse large B-cell lymphoma patients, reducing disease progression or death by 25%. The study’s findings support regulatory submissions for tafasitamab as a first-line treatment, potentially expanding its use in lymphoma. Read more
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Incyte’s Tafasitamab Shows Improved Outcomes in DLBCL at ASCO
Incyte’s Phase III frontMIND study revealed that the combination of tafasitamab, lenalidomide, and R-CHOP significantly improved progression-free survival in high-risk diffuse large B-cell lymphoma patients, reducing disease progression or death by 25%. The study’s findings support regulatory submissions for tafasitamab as a first-line treatment, potentially expanding its use in lymphoma. Read more
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Pfizer’s Braftovi Regimen Nearly Doubles Progression-Free Survival in Metastatic Colorectal Cancer
Pfizer’s Braftovi-based regimen significantly improved outcomes in previously untreated BRAF V600E-mutant metastatic colorectal cancer, nearly doubling median progression-free survival to 15.2 months. The treatment reduced disease progression risk by 56% and overall survival risk by 44%. These findings highlight the potential of targeted therapies in addressing this aggressive cancer subtype. Read more
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AstraZeneca’s EMERALD-3: Breakthrough in Liver Cancer Treatment
AstraZeneca’s Phase III EMERALD-3 trial found that the combination of Imfinzi, Imjudo, lenvatinib, and transarterial chemoembolisation significantly improved progression-free survival in patients with unresectable hepatocellular carcinoma compared to TACE alone. These findings may facilitate expanding immunotherapy usage into earlier stages of liver cancer, enhancing treatment options. Read more
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FDA approves Wockhardt’s first-in-class Zaynich opening $9 billion resistant infection market
Wockhardt’s Zaynich (cefepime-zidebactam) has gained FDA approval for treating complicated urinary tract infections in adults, marking a significant advance in combating multidrug-resistant Gram-negative pathogens. This new antibiotic class enhances cefepime’s efficacy, addressing the urgent need for innovative solutions against rising antimicrobial resistance in healthcare settings. Read more
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FDA Proposes Streamlined Animal Testing for Oncology Drugs
The FDA has proposed draft guidance to streamline nonclinical safety study requirements for oncology biologics, aiming to reduce unnecessary animal testing. The guidance allows for limited animal studies and promotes alternative methods to accelerate drug development while ensuring safety. It reflects a regulatory shift towards more human-centric assessment technologies in oncology. Read more