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Page 11 - Us Fda

Not just pledge, here's what will build public confidence in Covid vaccine

The Trump administration has exerted relentless political pressure on public health officials to approve a vaccine quickly, with the president pushing for a vaccine by Election Day

Not just pledge, here's what will build public confidence in Covid vaccine
Updated On : 15 Sep 2020 | 10:26 AM IST

Zydus Cadila gets tentative US FDA approval for generic diabetes drug

Drug firm Zydus Cadila said it has received approval from the US health regulator to market diabetes drug, Empagliflozin and Linagliptin tablets, in the US market

Zydus Cadila gets tentative US FDA approval for generic diabetes drug
Updated On : 09 Sep 2020 | 3:52 PM IST

Strides Pharma gets US FDA nod for generic anti-inflammatory drug

Drug firm Strides Pharma Science on Thursday said it has received approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication. Strides Pharma Global Pte Ltd, Singapore, company's step-down wholly owned subsidiary, has received approval for Prednisone tablets USP in the strength of 1 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a filing to the BSE. The product is a generic version of Schering Corporation's Meticorten tablets in the same strength, it added. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market,the filing said. According to IQVIA MAT July 2020 data, the US market for Prednisone tablets USP 1 mg is approximately USD 12 million (about Rs 88 crore), it added. Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication. It i

Strides Pharma gets US FDA nod for generic anti-inflammatory drug
Updated On : 03 Sep 2020 | 5:23 PM IST

US FDA-approved ointment found to treat, kill infections including Covid

Scientists associated with the project said the FDA-registered non-prescription over the counter (OTC) ointment has been proven to prevent, treat and kill viral infections including coronavirus

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Updated On : 22 Aug 2020 | 8:37 AM IST

Gilead seeks US FDA approval for experimental coronavirus drug remdesivir

The antiviral drug has been at the forefront of the battle against the pandemic after the FDA granted it emergency use authorization (EUA) in May

Gilead seeks US FDA approval for experimental coronavirus drug remdesivir
Updated On : 11 Aug 2020 | 7:46 AM IST

US FDA approves GlaxoSmithKline's experimental drug for blood cancer

Multiple myeloma is the second most common form of blood cancer in the US and is generally considered treatable, but not curable

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Updated On : 06 Aug 2020 | 10:28 AM IST

AstraZeneca's drug gets US FDA nod to treat lung disease patients

The drug Breztri Aerosphere is being approved as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), the third leading cause of death globally

AstraZeneca's drug gets US FDA nod to treat lung disease patients
Updated On : 28 Jul 2020 | 9:06 PM IST

US approved 4 Covid-19 vaccine candidates for clinical trials: FDA head

The US Administration launched in May Operation Warp Speed, a joint project of Health and Defense Departments, which aims to deliver 300 million doses of a vaccine for Covid-19 by January 2021

US approved 4 Covid-19 vaccine candidates for clinical trials: FDA head
Updated On : 01 Jul 2020 | 8:39 AM IST

US Health Secy tells docs to prescribe HCQ as FDA withdraws use in Covid-19

During a White House media appearance with President Donald Trump, Azar asserted that HCQ was approved in the United States

US Health Secy tells docs to prescribe HCQ as FDA withdraws use in Covid-19
Updated On : 16 Jun 2020 | 8:19 AM IST

UK begins trial of latest virus vaccine this week with 300 candidates

The British government said 300 healthy people will be immunized with two doses of the Covid-19 vaccine candidate developed at Imperial, which has been backed by 41 million pounds

UK begins trial of latest virus vaccine this week with 300 candidates
Updated On : 16 Jun 2020 | 7:59 AM IST

US FDA ends emergency use of hydroxychloroquine to treat Covid-19

The decision on the so-called 'wonder drug' as touted by the US President Donald Trump is taken in the wake of recent clinical trials

US FDA ends emergency use of hydroxychloroquine to treat Covid-19
Updated On : 16 Jun 2020 | 7:38 AM IST
Lupin steps up production of key drugs in potential use for Covid-19
Updated On : 31 May 2020 | 10:43 PM IST

Opportunity in crisis: 5 sectors that may gain from coronavirus pandemic

As India moves to open up the country, investors look at sectors that have been resilient. Puneet Wadhwa charts sectors that are expected to do well in the next few months

Opportunity in crisis: 5 sectors that may gain from coronavirus pandemic
Updated On : 30 May 2020 | 6:13 PM IST

Investors should stick to stocks of firms focused on domestic market

Pharma firms can build brands and enjoy higher margins here

Investors should stick to stocks of firms focused on domestic market
Updated On : 24 Apr 2020 | 1:14 AM IST
India growth crucial for Torrent Pharma's health amid steep fall in volume
Updated On : 07 Apr 2020 | 3:03 AM IST

Malaysia plant boosts Biocon prospects in US and other key markets

Firm seen benefiting from operating leverage, biologic sales by FY22

Malaysia plant boosts Biocon prospects in US and other key markets
Updated On : 03 Apr 2020 | 11:36 PM IST

Covid-19 throws up drug supply opportunity for Ipca, other pharma firms

Sun Pharma, Dr Reddy's, Torrent Pharma, Cipla, Cadila Healthcare and Natco Pharma would also benefit from malaria drug supplies, Alembic Pharma from azithromycin sales

Covid-19 throws up drug supply opportunity for Ipca, other pharma firms
Updated On : 23 Mar 2020 | 11:22 PM IST

Glenmark gets US FDA nod for tablet used to treat high levels of iron

Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US health regulator for Deferasirox tablets for oral suspension. "Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg, the generic version of exjade1 tablets for oral suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation," the company said in a filing to the BSE. The tablet is used to treat high levels of iron in the body caused by multiple blood transfusions. According to IQVIA sales data for the 12-month period ending November 2019, exjade tablets for oral suspension -- 125 mg, 250 mg and 500 mg -- had annual sales of approximately USD 106.4 million (about Rs 750 crore). Glenmark's current portfolio consists of 165 products authorised for distribution in the US market and 43 ANDAs pending approval with the US FDA. In addition

Glenmark gets US FDA nod for tablet used to treat high levels of iron
Updated On : 07 Jan 2020 | 11:29 AM IST

US health regulator sends stern letter to GPT Pharma about Hyderabad plant

The company has 15 working days to explain to the Food and Drug Administration how it has improved manufacturing standards.

US health regulator sends stern letter to GPT Pharma about Hyderabad plant
Updated On : 05 Jan 2020 | 11:29 AM IST

Over-prescribing antibiotics hurting children in poor countries: Lancet

The researchers, including those from Harvard University in the US, said one major factor contributing to this global health crisis is the excessive use of antibiotics worldwide

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Updated On : 14 Dec 2019 | 2:40 PM IST