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

07 Jul 2026

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

07 Jul 2026

Inhaled nitrous oxide provides efficacious analgesia for outpatient hysteroscopic procedures

06 Jul 2026

The use of inhaled nitrous oxide during outpatient operative hysteroscopy helps reduce intraprocedural pain and promote successful completion of procedures, resulting in increased patient satisfaction, according to a study.

Inhaled nitrous oxide provides efficacious analgesia for outpatient hysteroscopic procedures

06 Jul 2026

Dual immune checkpoint blockade delivers encouraging survival benefit in LACC

06 Jul 2026 bởi

Neoadjuvant nivolumab plus ipilimumab followed by chemoradiation and maintenance nivolumab yields high survival rates in locally advanced cervical cancer (LACC), according to final survival data from the phase II COLIBRI-1 trial.

Dual immune checkpoint blockade delivers encouraging survival benefit in LACC

06 Jul 2026

Switching to entecavir reduces relapse, flare in HBeAg-negative patients

06 Jul 2026

In hepatitis B e antigen-negative (HBeAg) patients, the last antiviral agent used prior to end of therapy (EOT) appears predictive of the timing of clinical relapse, according to a study. An entecavir-switching strategy may prevent relapse and reduce hepatitis flare and its severity within 24 weeks after EOT.

Switching to entecavir reduces relapse, flare in HBeAg-negative patients

06 Jul 2026

Pulse steroid therapy tied to bone turnover marker suppression, but not BMD loss

06 Jul 2026 bởi

Pulse intravenous methylprednisolone does not induce short-term loss of lumbar spine or hip bone mineral density (BMD), reports a Singapore study. However, it does suppress bone turnover markers, suggesting early effects on bone remodelling that are not captured by BMD alone.

Pulse steroid therapy tied to bone turnover marker suppression, but not BMD loss

06 Jul 2026

Anticoagulants up risk of bleeding after esophageal dilation procedure

06 Jul 2026

Patients taking anticoagulant medications at the time of esophageal dilation are at increased risk of experiencing gastrointestinal bleeding after the procedure, suggests a study.

Anticoagulants up risk of bleeding after esophageal dilation procedure

06 Jul 2026

Pooled analysis validates iptacopan safety for PNH

06 Jul 2026 bởi

A pooled analysis presented at EHA 2026 demonstrates the long-term safety of the oral proximal complement inhibitor iptacopan in the treatment of paroxysmal nocturnal haemoglobinuria (PNH).

Pooled analysis validates iptacopan safety for PNH

06 Jul 2026

High-dose cannabidiol offers relief in patients with chronic neuropathic pain

06 Jul 2026

In the treatment of patients with chronic neuropathic pain, high-dose cannabidiol (CBD) helps reduce pain intensity and is well-tolerated, according to a crossover study.

High-dose cannabidiol offers relief in patients with chronic neuropathic pain

06 Jul 2026

Upfront immunosuppression regimen improves survival in acquired haemophilia A

05 Jul 2026 bởi

In the first-line treatment of acquired haemophilia A (AHA), the use of an intravenous (IV) pulse-dose immunosuppression regimen that combines cyclophosphamide, dexamethasone, and rituximab appears to result in faster remission and improved survival compared with traditional oral sequential prednisone-based regimens, according to a study.

Upfront immunosuppression regimen improves survival in acquired haemophilia A

05 Jul 2026

Novel oral small-molecule PCSK9 inhibitor shows promise in hypercholesterolemia

04 Jul 2026

In the treatment of hypercholesterolemia, the investigational oral small-molecule PCSK9 inhibitor laroprovstat appears well tolerated and may help reduce low-density lipoprotein cholesterol (LDL-C) levels when used in combination with rosuvastatin, according to a phase I study.

Novel oral small-molecule PCSK9 inhibitor shows promise in hypercholesterolemia

04 Jul 2026

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

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

Inhaled nitrous oxide provides efficacious analgesia for outpatient hysteroscopic procedures

Inhaled nitrous oxide provides efficacious analgesia for outpatient hysteroscopic procedures

Dual immune checkpoint blockade delivers encouraging survival benefit in LACC

Dual immune checkpoint blockade delivers encouraging survival benefit in LACC

Switching to entecavir reduces relapse, flare in HBeAg-negative patients

Switching to entecavir reduces relapse, flare in HBeAg-negative patients

Pulse steroid therapy tied to bone turnover marker suppression, but not BMD loss

Pulse steroid therapy tied to bone turnover marker suppression, but not BMD loss

Anticoagulants up risk of bleeding after esophageal dilation procedure

Anticoagulants up risk of bleeding after esophageal dilation procedure

Pooled analysis validates iptacopan safety for PNH

Pooled analysis validates iptacopan safety for PNH

High-dose cannabidiol offers relief in patients with chronic neuropathic pain

High-dose cannabidiol offers relief in patients with chronic neuropathic pain

Upfront immunosuppression regimen improves survival in acquired haemophilia A

Upfront immunosuppression regimen improves survival in acquired haemophilia A

Novel oral small-molecule PCSK9 inhibitor shows promise in hypercholesterolemia

Novel oral small-molecule PCSK9 inhibitor shows promise in hypercholesterolemia