News & Updates

Original New Drug Application Approvals by US FDA (01 - 15 May 2020)

15 May 2020

New drug applications approved by US FDA as of 01 - 15 May 2020 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 May 2020)

15 May 2020

DTG/FTC/TAF a suitable ART regimen in pregnancy

14 May 2020 by

The combination of dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide fumarate (TAF) has superior virologic efficacy and safety compared with an efavirenz (EFV)/FTC/tenofovir disoproxil fumarate (TDF) combination in pregnant women living with HIV (WLHIV), results of the IMPAACT 2010/VESTED* trial showed.

DTG/FTC/TAF a suitable ART regimen in pregnancy

14 May 2020

PF-06700841 shows therapeutic potential in moderate-to-severe plaque psoriasis

14 May 2020

The oral TYK2/JAK1 inhibitor PF-06700841 appears to be effective in the treatment of patients with moderate-to-severe plaque psoriasis, with a tolerable safety profile, according to the results of a phase IIa study.

PF-06700841 shows therapeutic potential in moderate-to-severe plaque psoriasis

14 May 2020

Evolocumab plus statin delivers no impact on cognition

14 May 2020

Evolocumab added to maximally tolerated statin therapy does not improve the cognitive performance of patients, even those who have achieved low-density lipoprotein cholesterol (LDL-C) levels <20 mg/dl, a recent study has shown.

Evolocumab plus statin delivers no impact on cognition

14 May 2020

Subgroup findings boost benefit of niraparib in newly-diagnosed ovarian cancer

14 May 2020 by

The PARP* inhibitor niraparib improves progression-free survival (PFS) and is well-tolerated in women with newly diagnosed advanced ovarian cancer (OCa) after a response to first-line (1L) platinum-based chemotherapy (CT), subgroup results of the phase III PRIMA/ENGOT-OV26/GOG-3012 trial have shown.

Subgroup findings boost benefit of niraparib in newly-diagnosed ovarian cancer

14 May 2020

Second patient cured of HIV through stem cell transplant

13 May 2020 by

The second HIV patient to successfully undergo stem cell transplantation is still in remission, a good 30 months after stopping antiretroviral therapy (ART) — raising hope that curing HIV is a possibility.

Second patient cured of HIV through stem cell transplant

13 May 2020

Gemcitabine plus albumin-bound paclitaxel useful for treating advanced SQCLC

13 May 2020

The combination of gemcitabine plus albumin-bound paclitaxel (ABP) appears to be well tolerated and effective in the first-line treatment of patients with advanced squamous cell lung cancer (SQCLC), according to the results of a phase II study.

Gemcitabine plus albumin-bound paclitaxel useful for treating advanced SQCLC

13 May 2020

Ixekizumab COASTs through r-axSpA with sustained efficacy, safety

13 May 2020 by

Two phase III trials reflect the sustained efficacy and safety of the bDMARD* ixekizumab in bDMARD-naïve (COAST-V) or TNFi**-experienced (COAST-W) adults with active radiographic axial spondyloarthritis (r-axSpA), also known as ankylosing spondylitis (AS).

Ixekizumab COASTs through r-axSpA with sustained efficacy, safety

13 May 2020

Rifabutin-based triple therapy wipes out H. pylori in infected patients

13 May 2020

The novel rifabutin-based triple therapy (RHB-105) delivers promising outcomes as first-line empirical treatment for Helicobacter pylori eradication, according to the results of a phase III, double blind trial. This therapy addresses the challenge of rising antibiotic resistance in the current environment.

Rifabutin-based triple therapy wipes out H. pylori in infected patients

13 May 2020

Switching to second, third TNFi tied to lower drug survival, response rates in PsA patients

13 May 2020

Patients with axial and peripheral psoriatic arthritis (PsA) who switch to a second or third tumour necrosis factor inhibitor (TNFi) have significantly lower drug survival and response rates, a recent study has found.

Switching to second, third TNFi tied to lower drug survival, response rates in PsA patients

13 May 2020

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Original New Drug Application Approvals by US FDA (01 - 15 May 2020)

Original New Drug Application Approvals by US FDA (01 - 15 May 2020)

DTG/FTC/TAF a suitable ART regimen in pregnancy

DTG/FTC/TAF a suitable ART regimen in pregnancy

PF-06700841 shows therapeutic potential in moderate-to-severe plaque psoriasis

PF-06700841 shows therapeutic potential in moderate-to-severe plaque psoriasis

Evolocumab plus statin delivers no impact on cognition

Evolocumab plus statin delivers no impact on cognition

Subgroup findings boost benefit of niraparib in newly-diagnosed ovarian cancer

Subgroup findings boost benefit of niraparib in newly-diagnosed ovarian cancer

Second patient cured of HIV through stem cell transplant

Second patient cured of HIV through stem cell transplant

Gemcitabine plus albumin-bound paclitaxel useful for treating advanced SQCLC

Gemcitabine plus albumin-bound paclitaxel useful for treating advanced SQCLC

Ixekizumab COASTs through r-axSpA with sustained efficacy, safety

Ixekizumab COASTs through r-axSpA with sustained efficacy, safety

Rifabutin-based triple therapy wipes out H. pylori in infected patients

Rifabutin-based triple therapy wipes out H. pylori in infected patients

Switching to second, third TNFi tied to lower drug survival, response rates in PsA patients

Switching to second, third TNFi tied to lower drug survival, response rates in PsA patients