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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

Original New Drug Application Approvals by US FDA (1-15 April 2026)

29 Apr 2026

New drug applications approved by US FDA as of 1-15 April 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 (1-15 April 2026)

29 Apr 2026

Prenatal exposure to buprenorphine does not lead to adverse neurodevelopmental outcomes in kids

28 Apr 2026 by

Children with prenatal exposure to buprenorphine do not appear to have an elevated risk of long-term adverse neurodevelopmental outcomes relative to those exposed to methadone, suggests a study.

Prenatal exposure to buprenorphine does not lead to adverse neurodevelopmental outcomes in kids

28 Apr 2026

Low-FODMAP diet, rifaximin equally efficacious in IBS with diarrhoea

28 Apr 2026

In patients with diarrhoea-predominant inflammatory bowel disease (IBS-D), a low FODMAP diet (LFD) intervention and rifaximin treatment both result in improved outcomes, as shown in a study.

Low-FODMAP diet, rifaximin equally efficacious in IBS with diarrhoea

28 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

Novel neurokinin 3 receptor antagonist for VMS clears phase II study

25 Apr 2026

Treatment with the neurokinin 3 receptor antagonist GS1-144 appears to help reduce the frequency and severity of vasomotor symptoms (VMS) in postmenopausal Chinese women, according to a phase II study.

Novel neurokinin 3 receptor antagonist for VMS clears phase II study

25 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

Statin-ezetimibe holds slight advantage over PCSK9is in ACS

24 Apr 2026 by

In a systematic review and network meta-analysis (NMA), a statin-ezetimibe combination yields a more favourable LDL-C reduction and a positive trend in atherosclerotic plaque regression compared with PCSK9 inhibitors (PCSK9is) alone in individuals with acute coronary syndrome (ACS).

Statin-ezetimibe holds slight advantage over PCSK9is in ACS

24 Apr 2026

GLP-1RAs offer histologic benefits in MASH without fibrosis progression

23 Apr 2026 by

Treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide and liraglutide, improves histologic outcomes in patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) without compromising safety, reports a Singapore study.

GLP-1RAs offer histologic benefits in MASH without fibrosis progression

23 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)

Original New Drug Application Approvals by US FDA (1-15 April 2026)

Original New Drug Application Approvals by US FDA (1-15 April 2026)

Prenatal exposure to buprenorphine does not lead to adverse neurodevelopmental outcomes in kids

Prenatal exposure to buprenorphine does not lead to adverse neurodevelopmental outcomes in kids

Low-FODMAP diet, rifaximin equally efficacious in IBS with diarrhoea

Low-FODMAP diet, rifaximin equally efficacious in IBS with diarrhoea

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

Novel neurokinin 3 receptor antagonist for VMS clears phase II study

Novel neurokinin 3 receptor antagonist for VMS clears phase II study

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

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

Statin-ezetimibe holds slight advantage over PCSK9is in ACS

Statin-ezetimibe holds slight advantage over PCSK9is in ACS

GLP-1RAs offer histologic benefits in MASH without fibrosis progression

GLP-1RAs offer histologic benefits in MASH without fibrosis progression