FDA Archives - Page 3 of 6 - Journal for Clinical Studies

Regional News

Johnson & Johnson wins FDA panel backing for a second dose of its COVID shot but don’t call it a ‘booster’

Over the last year, the Johnson & Johnson COVID-19 vaccine has been commonly referred to as a single-shot alternative to the two-dose regimens of mRNA vaccines fr...

20 October 2021 Regional News COVID-19 | FDA

Continue Reading →

Regional News

Revance’s Botox rival turned away by FDA after inspectors flagged manufacturing ‘deficiencies’

Despite a pandemic delay and an FDA warning about quality control and record-keeping problems at a production site, Revance insisted it was optimistic the agency woul...

20 October 2021 Regional News Botox | DaxibotulinumtoxinA

Continue Reading →

Regional News

FDA delays decision on Moderna’s COVID-19 vaccine in 12-17 age group because of myocarditis concerns

After reports in four Nordic countries of the heart inflammation condition myocarditis, the FDA has delayed a decision on the Moderna COVID-19 shot for kids between t...

20 October 2021 Regional News COVID-19 | FDA

Continue Reading →

Regional News

FDA ready to bless mixing and matching of COVID-19 vaccines as boosters

Data from a National Institutes of Health (NIH) study on booster shots have convinced the FDA to allow Americans to use a different COVID-19 vaccine for a booster dos...

20 October 2021 Regional News booster | COVID-19

Continue Reading →

Volume 13 Issue 5

Scientific and Ethical Issues Surrounding the Enrolment of Pregnant People in Clinical Trials

Through recent actions, the US Food and Drug Administration (FDA) has signalled its commitment to advancing research in pregnant and lactating people, recognising tha...

18 October 2021 Volume 13 Issue 5 clinical trials | FDA

Continue Reading →

Regional News

Eyes itching from allergies? Ocular’s Dextenza wins FDA approval as first monthly implant

Patients with itchy eyes caused by allergic inflammation often take eye drops multiple times per day. Thanks to an FDA approval, a monthly insert into the canaliculus...

13 October 2021 Regional News allergic inflammation | Dextenza

Continue Reading →

Regional News

Racing rival Pfizer, Merck’s Vaxneuvance makes its case for an FDA approval in children

Time is of the essence for Merck as the company races with rival Pfizer to gain an FDA approval for its next-generation pneumococcal vaccine in children. The longer ...

6 October 2021 Regional News children | FDA

Continue Reading →

Regional News

Biohaven’s Nurtec, with dual migraine approvals, hits $136M in quarterly sales and leads the pack in market share

Biohaven's migraine drug Nurtec ODT has been on a roll since becoming the first medicine to win a dual FDA approval to both treat and prevent migraines. Now, the comp...

6 October 2021 Regional News anti-CGRP | Biohaven

Continue Reading →

Regional News

Amgen’s Repatha gains an edge on rival Praluent with FDA approval to treat children with rare cholesterol condition

Though it has struggled to live up to early commercial expectations, Amgen’s cholesterol treatment Repatha has largely had the best of its rival in the market, Sanofi...

29 September 2021 Regional News Amgen | cholesterol condition

Continue Reading →

Regional News

GlaxoSmithKline’s long-acting HIV drug nabs FDA priority review as a preventative option

GlaxoSmithKline’s long-acting HIV drug cabotegravir is already challenging market leaders as part of an approved treatment regimen. Now, the medicine is a step closer...

29 September 2021 Regional News cabotegravir | FDA

Continue Reading →

Derisking FIH Integrated Strategies

Current Edition

Johnson & Johnson wins FDA panel backing for a second dose of its COVID shot but don’t call it a ‘booster’

Revance’s Botox rival turned away by FDA after inspectors flagged manufacturing ‘deficiencies’

FDA delays decision on Moderna’s COVID-19 vaccine in 12-17 age group because of myocarditis concerns

FDA ready to bless mixing and matching of COVID-19 vaccines as boosters

Scientific and Ethical Issues Surrounding the Enrolment of Pregnant People in Clinical Trials

Eyes itching from allergies? Ocular’s Dextenza wins FDA approval as first monthly implant

Racing rival Pfizer, Merck’s Vaxneuvance makes its case for an FDA approval in children

Biohaven’s Nurtec, with dual migraine approvals, hits $136M in quarterly sales and leads the pack in market share

Amgen’s Repatha gains an edge on rival Praluent with FDA approval to treat children with rare cholesterol condition

GlaxoSmithKline’s long-acting HIV drug nabs FDA priority review as a preventative option

Journal for Clinical Studies