Page 28 - Usfda

USFDA okays emergency use of Gilead drug for hospitalised Covid-19 patients

Gilead CEO Daniel O'Day has announced that the company is donating 1.5 million vials of the medicine

FDA's lax blood test rules open US market to dubious vendors: Report

The rush to obtain test kits follows the FDA's unprecedented decision last month to allow any company to sell antibody tests in the US without prior review by the agency

Lupin gets inspection closure report from USFDA for Pithampur plant

Lupin Managing Director Nilesh Gupta, said the company has received the EIR for the plant with Voluntary Action Indicated (VAI) status

Diversified model, US outlook to help Dr Reddy's stock trade better

The company has multiple growth engines given its focus on India/emerging markets and limited competition products in the US

Battling Covid-19: Start-ups chip in to resolve India's ventilator crisis

Domestic firms are also sourcing ventilator parts from within the country to manufacture ventilators at a much lower cost

Covid-19: US FDA warns against use of hydroxychloroquine outside hospitals

Among some of side effects, heart rhythm abnormalities developed in most of the 84 coronavirus patients treated with hydroxychloroquine

US FDA clears Aurobindo Pharma Unit IV, reverts classification to VAI

The latest classification, VAI, suggests that though certain objectionable conditions were found during the review, they did not warrant any further regulatory action

USFDA may have dropped standards too far in hunt for Covid-19 drug: Report

Although some rules can be waived in an emergency, the FDA dropped its quality-control standards too far as it scoured the world for scarce supplies of chloroquine drugs.

Lupin pharma receives EIR from USFDA for Mandideep Unit II facility

The inspection at the facility was carried out by the US Food and Drug Administration between November 26, 2018

Clearance from US drug regulator key for Lupin to sustain stock gains

The recent gains came on Monday after the company received the USFDA approval for its Nagpur facility

Lupin gets EIR from USFDA for its manufacturing plant in Nagpur

The company's shares surged 4.14% to Rs 820.40 after they received the inspection report (EIR) from the US drug regulator

Coronavirus outbreak: Quick USFDA approvals for asthma drug makers

Cipla gets nod for drug from USFDA earlier than expected; Lupin in fray

China's recovery from coronavirus outbreak, drug demand lift pharma funds

Easing of supply chain issues, hydroxychloroquine opportunity boost sentiments

Zydus Cadila gets final nod from USFDA to market generic seizures drug

The group now has 283 approvals and has so far filed over 386 abbreviated new drug applications

Top headlines: Biz sentiment sinks to record low, Moody's outlook on banks

Business Standard brings to you the top headlines of the day

India may soon ease some drug export curbs under US pressure: Report

Imports from India accounted for 24% of medicines and 31% of medicine ingredients to the United States in 2018, according to the US Food and Drug Administration

USFDA approves AstraZeneca's combo treatment for lung cancer patients

The combo treatment has been approved in the United States for adult patients with extensive-stage small cell lung cancer, the company said

Lupin gets EIR from USFDA for Florida-based inhalation research centre

The Center at Coral Springs, Florida, focuses on research and development of respiratory products for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.

USFDA approves limited use of antimalarial drugs to treat Covid-19 patients

Two US medical bodies -- the National Institutes of Health and the Biomedical Advanced Research and Development Authority -- are currently working to plan such trials

Sun Pharma's product approvals at risk as USFDA labels Halol plant as OAI

Earlier in December, the plant had been issued Form 483 by USFDA with eight observations