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Original New Drug Application Approvals by US FDA (01-15 November 2023)

15 Nov 2023

New drug applications approved by US FDA as of 01-15 November 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 (01-15 November 2023)

15 Nov 2023

Thalidomide reduces recurrent GI bleeding in patients with small-intestinal angiodysplasia

15 Nov 2023 bởi

Among patients with recurrent gastrointestinal (GI) bleeding due to small-intestinal angiodysplasia (SIA), treatment with thalidomide resulted in fewer bleeding episodes compared with placebo, according to a recent study.

Thalidomide reduces recurrent GI bleeding in patients with small-intestinal angiodysplasia

15 Nov 2023

Paclitaxel-coated devices do not increase mortality risk

14 Nov 2023 bởi

An updated patient-level meta-analysis refutes claims that paclitaxel-coated devices for femoropopliteal interventional procedures heighten the risk of death. The recent study presented at TCT 2023 has found no association between exposure to paclitaxel and mortality.

Paclitaxel-coated devices do not increase mortality risk

14 Nov 2023

Shorter outshines longer DAPT for ACS patients following DES implantation

14 Nov 2023 bởi

In patients treated with drug-eluting stents (DES) for acute coronary syndrome (ACS), stopping aspirin within a month of dual antiplatelet therapy (DAPT) and continuing with ticagrelor alone outdid a 12-month DAPT regimen with ticagrelor and aspirin, findings from the T-PASS trial have shown.

Shorter outshines longer DAPT for ACS patients following DES implantation

14 Nov 2023

Botulinum toxin-A beneficial to children with treatment-resistant dysfunctional voiding

13 Nov 2023

In children with treatment-resistant dysfunctional voiding, the use of botulinum toxin-A (BTX-A) helps with postvoid residuals (PVR), urinary tract infections (UTIs), and incontinence, according to a study.

Botulinum toxin-A beneficial to children with treatment-resistant dysfunctional voiding

13 Nov 2023

Multimodal intervention reduces second-line antibiotic prescriptions for UTI

13 Nov 2023 bởi

A multimodal intervention applied in general practice results in a significant decrease in antibiotic prescribing and an increase in guideline adherence among women with uncomplicated urinary tract infection (UTI), a study has shown.

Multimodal intervention reduces second-line antibiotic prescriptions for UTI

13 Nov 2023

Melatonin helps improve pulmonary rehabilitation outcomes in COPD

13 Nov 2023

For patients with chronic obstructive pulmonary disease (COPD) who are undergoing pulmonary rehabilitation, melatonin supplementation leads to improvements in functional capacity, health status, and quality of life, as shown in a study.

Melatonin helps improve pulmonary rehabilitation outcomes in COPD

13 Nov 2023

JAK inhibitor use tied to increased odds of acne

12 Nov 2023

Exposure to Janus kinase (JAK) inhibitors potentially carries an increased likelihood of developing acne, according to a study.

JAK inhibitor use tied to increased odds of acne

12 Nov 2023

Add-on vancomycin of little help for surgical prophylaxis in arthroplasty

11 Nov 2023

Adding vancomycin to cefazolin does not appear to confer significant benefits for the prevention of surgical site infections following arthroplasty in patients without known methicillin-resistant Staphylococcus aureus (MRSA) colonization, according to the results of the ASAP trial.

Add-on vancomycin of little help for surgical prophylaxis in arthroplasty

11 Nov 2023

Induction chemotherapy before CRT ups survival in locally advanced cervical cancer

11 Nov 2023 bởi

Induction chemotherapy followed by chemoradiotherapy (CRT) significantly improves progression-free survival (PFS) and overall survival (OS) in patients with locally advanced cervical cancer compared with standard CRT alone, according to the INTERLACE trial presented at ESMO 2023.

Induction chemotherapy before CRT ups survival in locally advanced cervical cancer

11 Nov 2023

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Original New Drug Application Approvals by US FDA (01-15 November 2023)

Original New Drug Application Approvals by US FDA (01-15 November 2023)

Thalidomide reduces recurrent GI bleeding in patients with small-intestinal angiodysplasia

Thalidomide reduces recurrent GI bleeding in patients with small-intestinal angiodysplasia

Paclitaxel-coated devices do not increase mortality risk

Paclitaxel-coated devices do not increase mortality risk

Shorter outshines longer DAPT for ACS patients following DES implantation

Shorter outshines longer DAPT for ACS patients following DES implantation

Botulinum toxin-A beneficial to children with treatment-resistant dysfunctional voiding

Botulinum toxin-A beneficial to children with treatment-resistant dysfunctional voiding

Multimodal intervention reduces second-line antibiotic prescriptions for UTI

Multimodal intervention reduces second-line antibiotic prescriptions for UTI

Melatonin helps improve pulmonary rehabilitation outcomes in COPD

Melatonin helps improve pulmonary rehabilitation outcomes in COPD

JAK inhibitor use tied to increased odds of acne

JAK inhibitor use tied to increased odds of acne

Add-on vancomycin of little help for surgical prophylaxis in arthroplasty

Add-on vancomycin of little help for surgical prophylaxis in arthroplasty

Induction chemotherapy before CRT ups survival in locally advanced cervical cancer

Induction chemotherapy before CRT ups survival in locally advanced cervical cancer