Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 45

Results For "U.S.-Food-and-Drug-Administration"

461 News Found

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


USFDA grants distinct indication for Chronic Sleep Disorder
Drug Approval | August 13, 2021

USFDA grants distinct indication for Chronic Sleep Disorder

Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder


Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee
Drug Approval | August 12, 2021

Biocon Biologics and Viatris receive approval for first interchangeable biosimilar Semglee

The company is eligible for 12 months exclusivity from launch


ALS drug RADICAVA holds promise as it completes four years in US
News | August 10, 2021

ALS drug RADICAVA holds promise as it completes four years in US

Nearly 6,000 patients have been treated with the drug since 2017


Eagle Pharmaceuticals announces licensing agreement for Landiolol
Biotech | August 10, 2021

Eagle Pharmaceuticals announces licensing agreement for Landiolol

Deal signed with AOP Orphan for US commercial rights


QIAGEN receives U.S. FDA emergency use authorization to analyze over 30 samples per hour
Digitisation | August 10, 2021

QIAGEN receives U.S. FDA emergency use authorization to analyze over 30 samples per hour

QIAreach SARS-CoV-2 antigen test, developed in collaboration with Ellume, is easy to use and provides accurate and objective results in 2 to 15 minutes


Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay
Drug Approval | August 10, 2021

Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal Dx Lung and Colon Cancer Assay

The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients


FDA approves Nexviazyme for late-onset Pompe disease
Drug Approval | August 09, 2021

FDA approves Nexviazyme for late-onset Pompe disease

Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells


Dr Reddy’s relaunch Naproxen Sodium Tablets in the US
News | August 04, 2021

Dr Reddy’s relaunch Naproxen Sodium Tablets in the US

It is part of the company’s pain/analgesics portfolio of OTC products


Abbott receives FDA clearance for its imaging tech using AI
Digitisation | August 04, 2021

Abbott receives FDA clearance for its imaging tech using AI

Ultreon 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using AI -