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Original New Drug Application Approvals by US FDA (01 - 15 August 2022)

15 Aug 2022

New drug applications approved by US FDA as of 01 - 15 August 2022 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 (01 - 15 August 2022)

15 Aug 2022

Soticlestat shows promise in rare, severe forms of childhood epilepsy

14 Aug 2022

The investigational drug soticlestat (TAK-935) helps reduce seizure frequency in children with Dravet syndrome (DS) or Lennox–Gastaut syndrome (LGS), with its safety profile consistent with previous data, according to the results of the phase II ELEKTRA trial.

Soticlestat shows promise in rare, severe forms of childhood epilepsy

14 Aug 2022

Laparoscopic pancreaticoduodenectomy a feasible oncological intervention

14 Aug 2022

Laparoscopic pancreaticoduodenectomy (LPD) is associated with high rates of early morbidity, reoperation, and transition to laparotomy, reports a recent study. Nevertheless, LPD remains a viable alternative to open pancreaticoduodenectomy (OPD).

Laparoscopic pancreaticoduodenectomy a feasible oncological intervention

14 Aug 2022

HCV reinfection highest among people with ongoing injecting drug use

14 Aug 2022

Reinfection with hepatitis C virus (HCV) is low among people receiving opioid agonist therapy (OAT) but appears to be at its peak during the first 24 weeks following treatment completion and among those with ongoing injecting drug use and needle‒syringe sharing, a study has found.

HCV reinfection highest among people with ongoing injecting drug use

14 Aug 2022

Inverse salt sensitivity predicts CV damage in essential hypertension

14 Aug 2022

Individuals with either salt sensitivity (SS) or inverse salt sensitivity (ISS) appear to be at greater risk of cardiovascular (CV) events, reveals a study.

Inverse salt sensitivity predicts CV damage in essential hypertension

14 Aug 2022

Fear of recurrence common in cancer survivors, patients

14 Aug 2022

A large number of cancer survivors and patients fear disease recurrence, reports a recent meta-analysis. Healthcare providers should address this issue with their patients and be ready to recommend interventions when needed.

Fear of recurrence common in cancer survivors, patients

14 Aug 2022

Liver cirrhosis ups risks of adverse pregnancy outcomes

14 Aug 2022

The presence of liver cirrhosis is detrimental in pregnant women, being associated with elevated risks of maternal mortality as well as obstetric and foetal complications, a study has found.

Liver cirrhosis ups risks of adverse pregnancy outcomes

14 Aug 2022

Medical, personal factors affect continuation of active surveillance in men

14 Aug 2022

Men take into consideration both personal and medical factors when deciding to continue active surveillance, reports a recent study.

Medical, personal factors affect continuation of active surveillance in men

14 Aug 2022

Depression, anxiety, sleep troubles common in primary Sjögren’s syndrome

13 Aug 2022

Patients with primary Sjögren’s syndrome (pSS) show high levels of depression, anxiety, and sleep disturbances, reports a recent study. Cognitive impairments are also prevalent in this patient population.

Depression, anxiety, sleep troubles common in primary Sjögren’s syndrome

13 Aug 2022

Aquatic physical therapy boosts outcomes in women with breast cancer

13 Aug 2022

Women with breast cancer may benefit significantly from aquatic physical therapy, which reduces fatigue while also improving quality of life (QoL), reports a recent meta-analysis.

Aquatic physical therapy boosts outcomes in women with breast cancer

13 Aug 2022

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Original New Drug Application Approvals by US FDA (01 - 15 August 2022)

Original New Drug Application Approvals by US FDA (01 - 15 August 2022)

Soticlestat shows promise in rare, severe forms of childhood epilepsy

Soticlestat shows promise in rare, severe forms of childhood epilepsy

Laparoscopic pancreaticoduodenectomy a feasible oncological intervention

Laparoscopic pancreaticoduodenectomy a feasible oncological intervention

HCV reinfection highest among people with ongoing injecting drug use

HCV reinfection highest among people with ongoing injecting drug use

Inverse salt sensitivity predicts CV damage in essential hypertension

Inverse salt sensitivity predicts CV damage in essential hypertension

Fear of recurrence common in cancer survivors, patients

Fear of recurrence common in cancer survivors, patients

Liver cirrhosis ups risks of adverse pregnancy outcomes

Liver cirrhosis ups risks of adverse pregnancy outcomes

Medical, personal factors affect continuation of active surveillance in men

Medical, personal factors affect continuation of active surveillance in men

Depression, anxiety, sleep troubles common in primary Sjögren’s syndrome

Depression, anxiety, sleep troubles common in primary Sjögren’s syndrome

Aquatic physical therapy boosts outcomes in women with breast cancer

Aquatic physical therapy boosts outcomes in women with breast cancer