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Original New Drug Application Approvals by US FDA (16-31 March 2026)

29 Apr 2026

New drug applications approved by US FDA as of 16-31 March 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-31 March 2026)

29 Apr 2026

ICI efficacy in lung cancer not dictated by time of treatment

27 Apr 2026 by

In lung cancer patients receiving immune checkpoint inhibitors (ICIs), survival is not necessarily better when treatment is administered in the morning vs in the afternoon, according to the i-TIMES study.

ICI efficacy in lung cancer not dictated by time of treatment

27 Apr 2026

9-valent HPV vaccine also protective in males

27 Apr 2026

The 9-valent HPV vaccine helps prevent HPV-related cancers in adolescents and young adult males, as shown in a retrospective study.

9-valent HPV vaccine also protective in males

27 Apr 2026

$Prostate cancer patients on enzalutamide may be at risk of fall, fracture$

Prostate cancer patients on enzalutamide may be at risk of fall, fracture

24 Apr 2026

A recent study has found a higher prevalence of falls and fractures in prostate cancer patients receiving enzalutamide relative to those reported in previous clinical trials and postmarketing research.

Prostate cancer patients on enzalutamide may be at risk of fall, fracture

24 Apr 2026

SONIA: Does 1L vs 2L use of CDK4/6 inhibitors improve OS in HR+, ERBB2- ABC?

24 Apr 2026 by

A phase III randomized clinical trial (RCT) of 1,050 patients with hormone receptor–positive (HR-positive), ERBB2-negative advanced breast cancer (ABC) showed that first-line (1L) use of cyclin-dependent kinase (CDK) 4 and 6 inhibitors did not improve overall survival (OS) compared with second-line (2L) use. At the same time, a post hoc subgroup analysis suggested an OS benefit with 1L use of CDK4/6 inhibitors in premenopausal patients.

SONIA: Does 1L vs 2L use of CDK4/6 inhibitors improve OS in HR+, ERBB2- ABC?

24 Apr 2026

ROSELLA final analysis: 4-month OS increase with relacorilant in platinum-resistant ovarian cancer

23 Apr 2026 by

The final overall survival (OS) analysis of the phase III ROSELLA clinical trial reports an increase of 4.1 months in median OS in patients with platinum-resistant ovarian cancer who received relacorilant in addition to nab-paclitaxel vs those who received nab-paclitaxel alone.

ROSELLA final analysis: 4-month OS increase with relacorilant in platinum-resistant ovarian cancer

23 Apr 2026

Health supplements: Help or hype?

22 Apr 2026 by

A review of 19 meta-analyses shows mixed results on the effects of multivitamin and mineral (MVM) supplementation on health outcomes.

Health supplements: Help or hype?

22 Apr 2026

Optimizing prostate cancer outcomes with 177Lu-PSMA-617 radioligand therapy

22 Apr 2026 by

Radioligand therapy, which uses prostate-specific membrane antigen (PSMA)–targeted agents to deliver tumour‑focused radiation, has become a key treatment for metastatic castration‑resistant prostate cancer (mCRPC). At an industry‑sponsored meeting, Professor Kim-Nguyen Chi of the University of British Columbia in Vancouver, Canada, discussed how PSMA-targeted radioligand therapy, specifically lutetium 177–PSMA 617 (¹⁷⁷Lu-PSMA-617), is reshaping mCRPC management and optimizes outcomes.

Optimizing prostate cancer outcomes with 177Lu-PSMA-617 radioligand therapy

22 Apr 2026

Two models of palliative care yield similar outcomes in end-stage liver disease

21 Apr 2026

Palliative care delivered by hepatologists yields similar improvements in quality of life (QoL) of patients with end-stage liver disease (ESLD) and is associated with greater patient satisfaction compared with palliative care delivered by specialists, according to a study.

Two models of palliative care yield similar outcomes in end-stage liver disease

21 Apr 2026

Secondary bladder cancer after RT not uncommon in prostate cancer patients

21 Apr 2026 by

A secondary bladder cancer (SBC) rarely occurs among patients with localized prostate cancer who have been treated with radiotherapy (RT), but the incidence rate is not insignificant, reports a study presented at EAU 2026. When it does appear, it usually becomes the primary cause of death in this population.

Secondary bladder cancer after RT not uncommon in prostate cancer patients

21 Apr 2026

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Original New Drug Application Approvals by US FDA (16-31 March 2026)

Original New Drug Application Approvals by US FDA (16-31 March 2026)

ICI efficacy in lung cancer not dictated by time of treatment

ICI efficacy in lung cancer not dictated by time of treatment

9-valent HPV vaccine also protective in males

9-valent HPV vaccine also protective in males

Prostate cancer patients on enzalutamide may be at risk of fall, fracture

Prostate cancer patients on enzalutamide may be at risk of fall, fracture

SONIA: Does 1L vs 2L use of CDK4/6 inhibitors improve OS in HR+, ERBB2- ABC?

SONIA: Does 1L vs 2L use of CDK4/6 inhibitors improve OS in HR+, ERBB2- ABC?

ROSELLA final analysis: 4-month OS increase with relacorilant in platinum-resistant ovarian cancer

ROSELLA final analysis: 4-month OS increase with relacorilant in platinum-resistant ovarian cancer

Health supplements: Help or hype?

Health supplements: Help or hype?

Optimizing prostate cancer outcomes with 177Lu-PSMA-617 radioligand therapy

Optimizing prostate cancer outcomes with 177Lu-PSMA-617 radioligand therapy

Two models of palliative care yield similar outcomes in end-stage liver disease

Two models of palliative care yield similar outcomes in end-stage liver disease

Secondary bladder cancer after RT not uncommon in prostate cancer patients

Secondary bladder cancer after RT not uncommon in prostate cancer patients