News & Updates

Original New Drug Application Approvals by US FDA (16-30 June 2023)

01 Jul 2023

New drug applications approved by US FDA as of 16-30 June 2023 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 (16-30 June 2023)

01 Jul 2023

Another IBAT inhibitor makes its case in large PFIC trial

30 Jun 2023 by

The ileal bile acid transporter (IBAT) inhibitor maralixibat appears to quell itching and reduce serum bile acid concentration in children with progressive familial intrahepatic cholestasis (PFIC), while having a tolerable safety profile, according to data from the phase III MARCH-PFIC trial said to be the largest to date.

Another IBAT inhibitor makes its case in large PFIC trial

30 Jun 2023

Pembrolizumab plus gemcitabine/cisplatin improves survival in metastatic biliary tract cancer

30 Jun 2023 by

Treatment with pembrolizumab (pembro) in combination with gemcitabine and cisplatin (gem/cis) results in a statistically significant, clinically meaningful improvement in overall survival (OS) when compared with placebo plus gem/cis in patients with previously untreated metastatic or unresectable biliary tract cancer (BTC), results of the KEYNOTE-966 study have shown.

Pembrolizumab plus gemcitabine/cisplatin improves survival in metastatic biliary tract cancer

30 Jun 2023

Long-term data support teduglutide safety for SBS-IF

30 Jun 2023 by

In a pooled analysis of two long-term paediatric extension trials evaluating short bowel syndrome-associated intestinal failure (SBS-IF), the glucagon-like peptide-2 analogue teduglutide (TED) demonstrated a safety profile that aligned with previous data.

Long-term data support teduglutide safety for SBS-IF

30 Jun 2023

Does vitamin D therapy improve survival in patients with CKD?

30 Jun 2023

For patients with chronic kidney disease (CKD), vitamin D therapy does little to reduce the risk of all-cause death, according to a study.

Does vitamin D therapy improve survival in patients with CKD?

30 Jun 2023

$Faecal transplant helps teens with refractory IBS$

Faecal transplant helps teens with refractory IBS

29 Jun 2023 by

For adolescents with treatment-refractory irritable bowel syndrome (IBS), faecal microbiota transplantation (FMT) is safe and beneficial, easing abdominal pain and improving health-related quality of life, according to a study presented at ESPGHAN 2023.

Faecal transplant helps teens with refractory IBS

29 Jun 2023

Pegargiminase plus chemo improves survival in nonepithelioid pleural mesothelioma

29 Jun 2023 by

Chemotherapy with pemetrexed and cisplatin with ADI-PEG20 (pegargiminase), an arginine-depleting agent, results in better survival and demonstrates a favourable safety profile in patients with nonepithelioid pleural mesothelioma (PM), according to a study presented at AACR 2023.

Pegargiminase plus chemo improves survival in nonepithelioid pleural mesothelioma

29 Jun 2023

PPI use ups mortality risk in ICU patients

29 Jun 2023

Use of proton pump inhibitors (PPIs) for the prevention of stress ulceration appears to elevate the risk of mortality in patients admitted to the intensive care unit (ICU), reveals a study.

PPI use ups mortality risk in ICU patients

29 Jun 2023

DOACs as good as LMWH for recurrent VTE prevention in cancer patients

29 Jun 2023

For patients with cancer who have recurrent venous thromboembolism (VTE), direct oral anticoagulants (DOACs) compare favourably with low-molecular-weight heparin (LMWH) in terms of recurrence prevention, according to a study.

DOACs as good as LMWH for recurrent VTE prevention in cancer patients

29 Jun 2023

Real-world data back CV safety of JAK inhibitors

28 Jun 2023 by

Two real-world studies presented at EULAR 2023 reflected the cardiovascular (CV) safety of Janus kinase inhibitors (JAKi*) in patients with rheumatoid arthritis (RA).

Real-world data back CV safety of JAK inhibitors

28 Jun 2023

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Original New Drug Application Approvals by US FDA (16-30 June 2023)

Original New Drug Application Approvals by US FDA (16-30 June 2023)

Another IBAT inhibitor makes its case in large PFIC trial

Another IBAT inhibitor makes its case in large PFIC trial

Pembrolizumab plus gemcitabine/cisplatin improves survival in metastatic biliary tract cancer

Pembrolizumab plus gemcitabine/cisplatin improves survival in metastatic biliary tract cancer

Long-term data support teduglutide safety for SBS-IF

Long-term data support teduglutide safety for SBS-IF

Does vitamin D therapy improve survival in patients with CKD?

Does vitamin D therapy improve survival in patients with CKD?

Faecal transplant helps teens with refractory IBS

Faecal transplant helps teens with refractory IBS

Pegargiminase plus chemo improves survival in nonepithelioid pleural mesothelioma

Pegargiminase plus chemo improves survival in nonepithelioid pleural mesothelioma

PPI use ups mortality risk in ICU patients

PPI use ups mortality risk in ICU patients

DOACs as good as LMWH for recurrent VTE prevention in cancer patients

DOACs as good as LMWH for recurrent VTE prevention in cancer patients

Real-world data back CV safety of JAK inhibitors

Real-world data back CV safety of JAK inhibitors