Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 87

Results For "FDA"

1722 News Found

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
Drug Approval | August 19, 2021

FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump

It measures 9 French (3 millimetres) in diameter upon insertion and removal from the body. While in the heart, it expands to support the heart’s pumping function, providing flow greater than 3.5 L/min


FDA grants Emergency Use Authorization for next-generation Covid-19 assays
Digitisation | August 19, 2021

FDA grants Emergency Use Authorization for next-generation Covid-19 assays

Thermo Fisher’s kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes Covid-19


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.


Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Drug Approval | August 17, 2021

Lupin receives tentative U.S. FDA approval for Brivaracetam tablets

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older


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


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol


Pear Therapeutics’ three FDA authorised prescriptions available at OptumRx
Digitisation | August 11, 2021

Pear Therapeutics’ three FDA authorised prescriptions available at OptumRx

OptumRx to make Pear’s three commercial Prescription Digital Therapeutics accessible to patients with Optum formulary access.


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