News for 'United States Food and Drug Administration'

India acts to repair reputation as drugs exporter

India acts to repair reputation as drugs exporter

Rediff.com7 May 2014

As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.

Trump defends use of HCQ, says it works in early stages of COVID-19

Trump defends use of HCQ, says it works in early stages of COVID-19

Rediff.com29 Jul 2020

There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.

US President Biden gets COVID-19 vaccine booster shot

US President Biden gets COVID-19 vaccine booster shot

Rediff.com28 Sep 2021

Biden got a third Pfizer dose after booster doses were approved by federal health officials.

Markets end flat on caution ahead of Fed, RBI meet

Markets end flat on caution ahead of Fed, RBI meet

Rediff.com16 Sep 2013

The broader markets ended negatively with mid-caps and small-caps shedding 0.5 per cent on the BSE.

Over 1 million new COVID-19 cases reported in US

Over 1 million new COVID-19 cases reported in US

Rediff.com4 Jan 2022

The US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.

Now, Hospira under US FDA's lens

Now, Hospira under US FDA's lens

Rediff.com23 Dec 2013

Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy

Glenmark gets USFDA nod for skin infections cream

Glenmark gets USFDA nod for skin infections cream

Rediff.com30 Sep 2013

Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for it's Hydrocortisone Butyrate Cream USP (0.1 per cent), abbreviated new drug approval from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a statement.

Biden, wife to receive Pfizer COVID-19 vaccine on Monday

Biden, wife to receive Pfizer COVID-19 vaccine on Monday

Rediff.com19 Dec 2020

Biden previously told Jake Tapper of CNN that he would be "happy to" take the COVID-19 vaccine once US infectious disease expert Anthony Fauci said it was safe and he would get the injection in a public setting to prove it.

'We put pressure on Biden admn over vaccines'

'We put pressure on Biden admn over vaccines'

Rediff.com13 May 2021

'Supplies should start moving to the Serum Institute without any impediments.'

Pfizer Covid vaccine gets US experts' nod

Pfizer Covid vaccine gets US experts' nod

Rediff.com11 Dec 2020

The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.

J&J seeks permission for trial of 1-shot Covid vaccine in India

J&J seeks permission for trial of 1-shot Covid vaccine in India

Rediff.com20 Apr 2021

The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.

US gives clean chit to Maggi: Do you want it back?

US gives clean chit to Maggi: Do you want it back?

Rediff.com12 Aug 2015

Nestl India is preparing a blueprint for a possible relaunch.

India's drug inspectors hard-pressed to scrutinise factories

India's drug inspectors hard-pressed to scrutinise factories

Rediff.com7 Apr 2014

There are just 1,500 drug inspectors responsible for more than 10,000 factories in India

No plans to reduce workforce: Ranbaxy

No plans to reduce workforce: Ranbaxy

Rediff.com2 Oct 2013

The company has been reported to be retrenching staff.

SIIto test Novavax's Omicron-specific vaccine

SIIto test Novavax's Omicron-specific vaccine

Rediff.com6 Jun 2022

The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.

USFDA raises concerns about Ranbaxy's Toansa plant

USFDA raises concerns about Ranbaxy's Toansa plant

Rediff.com13 Jan 2014

All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.

Sharapova's intent questioned - Why was she taking banned heart drug?

Sharapova's intent questioned - Why was she taking banned heart drug?

Rediff.com9 Mar 2016

'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'

Markets end on a weak note dragged by pharma shares

Markets end on a weak note dragged by pharma shares

Rediff.com29 Mar 2016

Top 5 losers include Lupin, Cipla, Sun Pharma, Dr Reddy's Lab and GAIL down 1.6%-11%.

US warns Novartis on manufacturing violations at 2 India plants

US warns Novartis on manufacturing violations at 2 India plants

Rediff.com28 Oct 2015

US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.

US registers record day toll of 2,129; total at 25,000

US registers record day toll of 2,129; total at 25,000

Rediff.com15 Apr 2020

A record number of 2,129 of Americans died in one single day, the previous highest being 2,074 on April 10. New York has become the epicentre of the country's outbreak with 2,03,020 confirmed cases and 10,842 deaths so far.

UK health regulator withdraws nod for another Wockhardt unit

UK health regulator withdraws nod for another Wockhardt unit

Rediff.com22 Oct 2013

The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom, whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, Wockhardt said in a filing to the Bombay Stock Exchange.

US lifts mask guidance for fully vaccinated people

US lifts mask guidance for fully vaccinated people

Rediff.com14 May 2021

The recommendation holds true for both indoors and outdoors, the CDC said.

Ranbaxy recalls some batches of generic Lipitor in latest quality blow

Ranbaxy recalls some batches of generic Lipitor in latest quality blow

Rediff.com10 Mar 2014

The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.

Rosier year-end seen for Indian pharma, thanks to faster US approvals

Rosier year-end seen for Indian pharma, thanks to faster US approvals

Rediff.com12 Oct 2015

Rosier year-end seen for Indian pharma thanks to faster US approvals.

New test can predict your level of immunity against COVID-19

New test can predict your level of immunity against COVID-19

Rediff.com10 Aug 2022

Easy access to this kind of test could help people determine what kind of precautions they should take against COVID-19 infection, such as getting an additional booster shot, the researchers said.

Regulator finds procedural lapses at Wockhardt's US facility

Regulator finds procedural lapses at Wockhardt's US facility

Rediff.com3 Jun 2014

The FDA had imposed a ban on the company's Waluj plant in May.

Serum to double Covid vaccine output in 2022

Serum to double Covid vaccine output in 2022

Rediff.com13 Jul 2021

SII would be scaling up its AstraZeneca-Oxford vaccine manufacturing capacity to 200 million doses a month from 100 million a month now, reports Sohini Das.

3-member panel to probe gas leak at Dr Reddy's

3-member panel to probe gas leak at Dr Reddy's

Rediff.com24 Dec 2010

A three-member committee, comprising two officials from the Director of Factories and one pharma expert, will probe the gas leak at a production unit of Dr Reddy's Laboratories (DRL). The Director of Factories will appoint a pharma domain expert soon.

Aurobindo Pharma embroiled in patent cases in the US

Aurobindo Pharma embroiled in patent cases in the US

Rediff.com28 Apr 2014

According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.

Maharashtra caps mask prices, N-95 to cost max Rs 49

Maharashtra caps mask prices, N-95 to cost max Rs 49

Rediff.com21 Oct 2020

The Maharashtra government has capped the prices of N-95, double and triple layer masks for suppliers and private hospitals in the wake of the Covid-19 pandemic, state health minister Rajesh Tope has said.

Kejriwal needs no insulin: Tihar; Wife says they want to kill him

Kejriwal needs no insulin: Tihar; Wife says they want to kill him

Rediff.com21 Apr 2024

The Aam Aadmi Party on Sunday said Tihar authorities were 'lying' about specialist doctors examining Delhi Chief Minister Arvind Kejriwal, while his wife Sunita Kejriwal alleged that he was being denied insulin for diabetes as 'they want to kill' him.

Trump requests Modi to release Hydroxychloroquine ordered by US

Trump requests Modi to release Hydroxychloroquine ordered by US

Rediff.com5 Apr 2020

India's Directorate General of Foreign Trade on March 25 banned the export of Hydroxychloroquine but said that certain shipments on humanitarian grounds may be allowed on a case-by-case basis. With more than three lakh confirmed cases of coronavirus infection and over 8,000 fatalities, the US has emerged as the worst sufferers of the deadly coronavirus diseases to which there has been no cure.

US approves Johnson & Johnson's Covid vaccine

US approves Johnson & Johnson's Covid vaccine

Rediff.com28 Feb 2021

The Johnson and Johnson vaccine, which works with one dose instead of two, got approval on Saturday, the third vaccine cleared in the country after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.

US to unveil plans for global distribution of vaccine

US to unveil plans for global distribution of vaccine

Rediff.com2 Jun 2021

In the next two weeks, the United States will detail plans to equitably distribute about 80 million (8 crore) COVID-19 vaccine doses globally without 'political requirements' of those receiving them, Secretary of State Antony Blinken has said.

US gives full approval to Pfizer Covid vaccine

US gives full approval to Pfizer Covid vaccine

Rediff.com23 Aug 2021

More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.

In talks with India over 'expedited approval' of Covid vaccine: Pfizer

In talks with India over 'expedited approval' of Covid vaccine: Pfizer

Rediff.com3 May 2021

Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.

US court rejects Ranbaxy' plea to block launch by rival cos

US court rejects Ranbaxy' plea to block launch by rival cos

Rediff.com20 Nov 2014

US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.

USFDA denies Covaxin emergency use nod, to take 'full approval' route

USFDA denies Covaxin emergency use nod, to take 'full approval' route

Rediff.com11 Jun 2021

In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

Jaishankar 'endeavours' to expand vaccine production with US help

Jaishankar 'endeavours' to expand vaccine production with US help

Rediff.com29 May 2021

Calling COVID-19 pandemic and vaccines as one of the most important aspects of his discussions with top officials of the Biden administration, External Affairs Minister S Jaishankar has said the endeavour is to expand production of vaccines in India with assistance from the US.