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Health and Pharma is a new-generation international news and communication platform. Our goal is to collaborate with health science and pharma professionals to report directly from the news sources and strive to be recognized as a trusted news platform.

BEQALZI™ ( ) has become the first and only -approved BCL2 inhibitor for adults with relapsed or refractory mantle cell ...
05/17/2026

BEQALZI™ ( ) has become the first and only -approved BCL2 inhibitor for adults with relapsed or refractory mantle cell after at least two prior lines of systemic therapy, including a BTK inhibitor.
The accelerated approval is based on data from the Phase 1/2 BGB-11417-201 trial, where sonrotoclax achieved:
✅ Overall response rate: 52%
✅ Complete response rate: 16%
✅ Median time to response: 1.9 months
✅ Median duration of response: 15.8 months
https://healthandpharma.net/fda-sonrotoclax-beqalzi-mantle-cell-lymphoma

approved (trastuzumab deruxtecan) for two HER2+ early indications: neoadjuvant T-DXd followed by THP in Stage II o...
05/17/2026

approved (trastuzumab deruxtecan) for two HER2+ early indications: neoadjuvant T-DXd followed by THP in Stage II or III disease and adjuvant T-DXd for residual invasive disease after neoadjuvant therapy. DESTINY-Breast11 showed higher pCR, 67.3% versus 56.3%, while DESTINY-Breast05 reduced invasive recurrence or death by 53% versus T-DM1.
https://healthandpharma.net/fda-enhertu-trastuzumab-deruxtecan-breast-cancer-her2

has approved ( and cedazuridine) plus for newly diagnosed acute ( ) in adults aged 75 years or older, or those ...
05/14/2026

has approved ( and cedazuridine) plus for newly diagnosed acute ( ) in adults aged 75 years or older, or those ineligible for intensive induction . In the Phase 2 ASCERTAIN-V study, 41.6% of patients achieved complete remission, with median duration not reached, establishing the first FDA-approved all-oral combination regimen for this population.
https://healthandpharma.net/fda-inqovi-decitabine-cedazuridine-venetoclax-aml

A planned interim analysis of the Phase III VOLGA trial has shown that perioperative ( ) combined with neoadjuvant v...
05/14/2026

A planned interim analysis of the Phase III VOLGA trial has shown that perioperative ( ) combined with neoadjuvant vedotin significantly improved event-free survival and overall survival compared with standard of care in patients with muscle-invasive who were ineligible for, or had declined, cisplatin-based .
https://healthandpharma.net/imfinzi-durvalumab-imjudo-bladder-cancer-volga

has approved ( ) for adults with advanced, unresectable or metastatic NRG1 fusion+ after prior systemic therapy. I...
05/09/2026

has approved ( ) for adults with advanced, unresectable or metastatic NRG1 fusion+ after prior systemic therapy. In the Phase 2 eNRGy trial, the confirmed ORR was 36.8% among 19 evaluable patients, with responses lasting 2.8 to 12.9 months. The approval marks the first targeted treatment option for this rare, biomarker-defined cholangiocarcinoma population with high unmet need.
https://healthandpharma.net/fda-approves-bizengri-zenocutuzumab-cholangiocarcinoma

has granted Fast Track designation to , also known as , for unresectable or metastatic cutaneous . Dubodencel is a ...
05/08/2026

has granted Fast Track designation to , also known as , for unresectable or metastatic cutaneous . Dubodencel is a first-in-class, patient-derived, double-loaded dendritic cell . It combines lysate and amplified tumor-derived mRNA prepared from a patient’s own tumor specimen, aiming to stimulate a broad anti-tumor immune response.
https://healthandpharma.net/fda-designation-dubodencel-doc1021-cutaneous-melanoma

RNase H2 may represent a new therapeutic vulnerability in triple-negative . A new study from MD Anderson, published in ...
05/07/2026

RNase H2 may represent a new therapeutic vulnerability in triple-negative .
A new study from MD Anderson, published in Cell Reports Medicine, found that cells may rely on RNase H2 to survive high levels of DNA replication stress. When researchers inhibited , cells accumulated more DNA damage, growth was suppressed, and innate immune signals were activated.
The findings also suggest possible synergy with ATR inhibitors, , and immune checkpoint blockade, supporting further investigation of combination strategies.
https://healthandpharma.net/rnase-h2-exposes-triple-breast-cancer

has accepted sND Application for ( ) aiming to update its label with longer-term efficacy data in advanced ROS1+ non...
05/07/2026

has accepted sND Application for ( ) aiming to update its label with longer-term efficacy data in advanced ROS1+ non-small cell .
In updated TRUST-I data, TKI-naïve patients achieved a median duration of response of 49.7 months and median progression-free survival of 49.6 months, suggesting more than four years of sustained clinical benefit. In TRUST-II, TKI-pretreated patients had a median duration of response of 19.4 months.
https://healthandpharma.net/fda-taletrectinib-ibtrozi-snda-ros1-lung-cancer

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