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Page 26 - Usfda

Bengaluru tech firm to produce NASA-designed, US FDA-approved ventilators

The firm said it is among a handful of Indian companies licenced by NASA for meeting the worldwide acute shortage of ventilators needed in treating Covid-19 patients

Bengaluru tech firm to produce NASA-designed, US FDA-approved ventilators
Updated On : 23 Jul 2020 | 2:57 PM IST

Zydus gets USFDA nod for drug trials to treat chemotherapy-induced anemia

Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator to initiate clinical trials for its drug 'Desidustat' in treatment of chemotherapy-induced anemia

Zydus gets USFDA nod for drug trials to treat chemotherapy-induced anemia
Updated On : 23 Jul 2020 | 1:15 PM IST

Covid-19 treatment: A lowdown on possible cure and drugs being used

Business Standard takes a look at the common drugs that are being used in India for treating Covid-19 patients

Covid-19 treatment: A lowdown on possible cure and drugs being used
Updated On : 20 Jul 2020 | 12:38 AM IST

Zydus Cadila gets USFDA nod to market generic drug to treat headache

The drug will be manufactured at Nesher Pharma's manufacturing facility at St. Louis in the US, the drug firm says

Zydus Cadila gets USFDA nod to market generic drug to treat headache
Updated On : 18 Jul 2020 | 3:15 PM IST

Biogen seeks US approval for potential Alzheimer's drug, stock jumps

The number of people in the United States living with Alzheimer's, the most common form of dementia, is expected to triple to nearly 14 million by 2050 without effective treatments

Biogen seeks US approval for potential Alzheimer's drug, stock jumps
Updated On : 09 Jul 2020 | 1:07 AM IST

Debate on drug to treat Covid-19 politicised; India uses it: White House

The idea that hydroxychloroquine is a dangerous drug is 'just silly', says Peter Navarro, White House Office of Trade and Manufacturing Policy Director.

Debate on drug to treat Covid-19 politicised; India uses it: White House
Updated On : 08 Jul 2020 | 7:43 AM IST

FDA chief declines to back Donald Trump's 'harmless' coronavirus claim

US Food and Drug Administration Commissioner Hahn said the coronavirus pandemic is "a rapidly evolving situation" but stressed that the US "absolutely must take this seriously"

FDA chief declines to back Donald Trump's 'harmless' coronavirus claim
Updated On : 06 Jul 2020 | 1:44 PM IST

Policy flip-flops may puncture India's image as 'pharmacy of the world'

India supplies almost 20 per cent of the medicines consumed by the world. Every third tablet in the US market is from India

Policy flip-flops may puncture India's image as 'pharmacy of the world'
Updated On : 01 Jul 2020 | 10:54 PM IST

Sequoia-backed Qure.ai gets USFDA nod for CT scan, first for Indian AI firm

American regulator's decision covers four critical abnormalities identified by Qure.ai's emergency room product namely intracranial bleeds, mass effect, midline shift, and cranial fractures

Sequoia-backed Qure.ai gets USFDA nod for CT scan, first for Indian AI firm
Updated On : 01 Jul 2020 | 7:58 PM IST

USFDA to release guidance on Covid-19 vaccine approval: Report

Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a safe and effective vaccine through clinical trials

USFDA to release guidance on Covid-19 vaccine approval: Report
Updated On : 30 Jun 2020 | 7:44 PM IST

Zydus Cadila gets USFDA nod to market generic antihistamine tablets

The drug will be manufactured at the group's manufacturing facility in Ahmedabad

Zydus Cadila gets USFDA nod to market generic antihistamine tablets
Updated On : 24 Jun 2020 | 2:52 PM IST

USFDA removes partial lifting of import on API facility at Ratlam: Ipca Lab

USFDA had partially lifted import alert imposed on the company's API plant at Ratlam and formulations units at Pithampur in the same state and Piparia in Silvassa

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Updated On : 24 Jun 2020 | 12:49 PM IST

Shot of Hope: Equal access a hurdle after race to coronavirus vaccine

The second of a two-part series examines challenges linked to IPR and monopoly once Covid-19 vaccine is created

Shot of Hope: Equal access a hurdle after race to coronavirus vaccine
Updated On : 23 Jun 2020 | 1:01 AM IST

Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets

The tablet is the generic of Janssen Pharmaceuticals Inc's reference listed drug product Xarelto

Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets
Updated On : 22 Jun 2020 | 4:36 PM IST

Covid-19 crisis: Cipla launches generic remdesivir under brand name Cipremi

The USFDA had issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc for emergency use of remdesivir for the treatment of Covid-19 patients

Covid-19 crisis: Cipla launches generic remdesivir under brand name Cipremi
Updated On : 21 Jun 2020 | 10:36 PM IST

Unichem, Lupin recall high blood pressure drugs from US over quality issues

The specified batch, which is being recalled, has been manufactured at Unichem's Goa-based facility

Unichem, Lupin recall high blood pressure drugs from US over quality issues
Updated On : 21 Jun 2020 | 1:30 PM IST

Piramal Pharma Solutions to acquire G&W Laboratories' drug facility in US

The site has received certifications from the Food and Drug Administration and European Medicines Agency

Piramal Pharma Solutions to acquire G&W Laboratories' drug facility in US
Updated On : 20 Jun 2020 | 5:02 PM IST

Cadila Healthcare's Q4 PBT falls 14% to Rs 522 cr, total income rises 0.66%

Cadila has also been working on a DNA vaccine to fight Covid-19, which is currently in the animal testing stage

Cadila Healthcare's Q4 PBT falls 14% to Rs 522 cr, total income rises 0.66%
Updated On : 19 Jun 2020 | 11:02 PM IST

Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment

The product was indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, Alembic Pharma said

Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment
Updated On : 19 Jun 2020 | 3:21 PM IST

Glenmark Pharma gets USFDA nod for drug to treat multiple sclerosis

The capsules are used in the treatment of adult patients with relapsing forms of multiple sclerosis

Glenmark Pharma gets USFDA nod for drug to treat multiple sclerosis
Updated On : 19 Jun 2020 | 12:31 PM IST