News for 'US Food and Drugs Administration'

How Dr Reddy's plans to win the US market

How Dr Reddy's plans to win the US market

Rediff.com17 Mar 2017

The company has launched only 3 new products during 2015 when compared to 14 launches in 2014

UN chief says will take COVID-19 vaccine publicly, calls it his 'moral obligation'

UN chief says will take COVID-19 vaccine publicly, calls it his 'moral obligation'

Rediff.com10 Dec 2020

Guterres reiterated his call for a COVID-19 vaccine to be a global public good available to everywhere and particularly, available in Africa.

Novavax set for India launch with Serum Institute as partner

Novavax set for India launch with Serum Institute as partner

Rediff.com15 Jun 2021

The Covid-19 vaccine demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, reports Sohini Das

US FDA likely to inspect new Visakhapatnam arm of Divi's Labs in Jan

US FDA likely to inspect new Visakhapatnam arm of Divi's Labs in Jan

Rediff.com31 Dec 2013

The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.

Maggie on the boil! Madhuri, Amitabh feel the heat; case against Nestle

Maggie on the boil! Madhuri, Amitabh feel the heat; case against Nestle

Rediff.com30 May 2015

A case was lodged on Saturday against Nestle India in a local court here over safety standards of its Maggi product, while actors Amitabh Bachhan, Madhuri Dixit and Preity Zinta have also been separately dragged to the court for promoting the 'two-minute' noodles brand.

Wockhardt's Shendra unit set for key US test

Wockhardt's Shendra unit set for key US test

Rediff.com7 Jan 2014

If the company manages to get a go-ahead from the regulator for this plant, it might result in resumption of supplies of several of their products, barred from the US last year.

Compliance worries hit shares in India's top two drugmakers

Compliance worries hit shares in India's top two drugmakers

Rediff.com9 Nov 2015

Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform

Investors concerned about Wockhardt

Investors concerned about Wockhardt

Rediff.com17 Oct 2013

The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.

Explained: What USFDA full approval to Pfizer-BioNTech vaccine means

Explained: What USFDA full approval to Pfizer-BioNTech vaccine means

Rediff.com17 Sep 2021

Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.

Pursuing foreign companies since mid-2020 for possible vaccine imports: Govt

Pursuing foreign companies since mid-2020 for possible vaccine imports: Govt

Rediff.com27 May 2021

Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.

COVAX urges equal recognition of WHO approved vaccines

COVAX urges equal recognition of WHO approved vaccines

Rediff.com2 Jul 2021

Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.

Johnson & Johnson pauses Covid vaccine trial as participant falls ill

Johnson & Johnson pauses Covid vaccine trial as participant falls ill

Rediff.com13 Oct 2020

The company has not yet revealed details about the unexplained illness but has stopped trials while doctors find out if the illness was caused due to the vaccine or was a coincidence.

V G Somani: The head of DCGI known as man of actions, not of words

V G Somani: The head of DCGI known as man of actions, not of words

Rediff.com18 Jan 2021

'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'

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.

Indian drugmakers to pay higher facility fees on US hike

Indian drugmakers to pay higher facility fees on US hike

Rediff.com3 Aug 2014

The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products

New COVID-19 test can give results in just 45 minutes

New COVID-19 test can give results in just 45 minutes

Rediff.com29 Apr 2020

The test named the "SARS-CoV-2 DETECTR" is easy to implement and to interpret, and requires no specialised equipment, said researchers from the University of California, San Francisco in the US.

Sun Pharma to delist Ranbaxy on completion of $4-bn merger

Sun Pharma to delist Ranbaxy on completion of $4-bn merger

Rediff.com25 Mar 2015

The merger has fortified Sun Pharma's position.

Maha portfolios: Ajit Pawar gets finance; Aaditya tourism

Maha portfolios: Ajit Pawar gets finance; Aaditya tourism

Rediff.com5 Jan 2020

With this allocation of portfolios, the Sharad Pawar-led NCP has got most of the 'plum' ministries.

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.

'Believe me, nobody can do reassurance better than Mr Modi'

'Believe me, nobody can do reassurance better than Mr Modi'

Rediff.com1 Oct 2023

'You ain't seen anything yet,' EAM Jaishankar says about the India-US relationship.

Approval delays to hurt Indian pharma cos' US sales

Approval delays to hurt Indian pharma cos' US sales

Rediff.com13 Nov 2014

Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.

Another big blow for Ranbaxy

Another big blow for Ranbaxy

Rediff.com22 Aug 2014

Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.

Coronavirus crisis could stretch up to August, warns Trump

Coronavirus crisis could stretch up to August, warns Trump

Rediff.com17 Mar 2020

At least 85 people have died of coronavirus with the confirmed cases crossing 4,500 in the US.

Dr Reddy's: New launches to drive growth

Dr Reddy's: New launches to drive growth

Rediff.com28 Jun 2013

Analysts are eyeing bigger launches that will positively impact company's fortunes.

'Everybody's going to get infected'

'Everybody's going to get infected'

Rediff.com27 Dec 2021

'In the likelihood that Omicron is circulating, you have a much greater chance of getting infected now, than you did during the Age of Delta.'

Markets come off two-month highs; Nifty ends below 8,250; IT stocks drag

Markets come off two-month highs; Nifty ends below 8,250; IT stocks drag

Rediff.com6 Jan 2017

The BSE Midcap also cut all its intraday gains to shed 0.3% at close

Why 1,700 employees of Pfizer's India arm may lose their jobs

Why 1,700 employees of Pfizer's India arm may lose their jobs

Rediff.com10 Jan 2019

A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.

Centre may not get costly Pfizer vaccine

Centre may not get costly Pfizer vaccine

Rediff.com22 Dec 2020

At $37 per dose, the Pfizer vaccine is much more expensive compared to $3 per dose for the Covishield.

US FDA India head quits; regulator goes for rejig

US FDA India head quits; regulator goes for rejig

Rediff.com21 Jul 2014

Altaf Ahmed Lal, country head of the US Food and Drug Administration (US FDA) in India, has quit and so have a few other key officials at the American drug regulator's India office.

FSSAI-approved lab finds Maggi noodles safe

FSSAI-approved lab finds Maggi noodles safe

Rediff.com4 Aug 2015

Many countries found Maggi noodles to be safe for consumption.

US: First batch of COVID-19 vaccine roll out of Pfizer plant

US: First batch of COVID-19 vaccine roll out of Pfizer plant

Rediff.com14 Dec 2020

The vaccine arrives at a critical moment for the US. Hospitalisations due to COVID-19 hit record highs for the seventh day in a row on Saturday.

Trump suggests injecting disinfectant as COVID-19 treatment

Trump suggests injecting disinfectant as COVID-19 treatment

Rediff.com24 Apr 2020

Trump also raised the possibility of using light to combat the deadly viral infection.

3rd minister quits Yogi cabinet, 10th MLA to leave BJP in UP

3rd minister quits Yogi cabinet, 10th MLA to leave BJP in UP

Rediff.com14 Jan 2022

OBC leader Dharam Singh Saini on Thursday became the third minister to resign from the Uttar Pradesh cabinet this week, giving yet another jolt to the ruling Bharatiya Janata Party in the run-up to the assembly polls.

Regulator might inspect Wockhardt units

Regulator might inspect Wockhardt units

Rediff.com12 Jun 2013

Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.

Wockhardt: Recovery not in sight yet

Wockhardt: Recovery not in sight yet

Rediff.com5 Nov 2014

The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.

Trump's health secy quits over plane scandal

Trump's health secy quits over plane scandal

Rediff.com30 Sep 2017

The names of two Indian-Americans -- Seema Verma and Bobby Jindal -- have emerged as possible candidates.

What is ailing India's pharma sector?

What is ailing India's pharma sector?

Rediff.com18 Aug 2016

Low growth visibility and trouble with regulators have resulted in lack of interest from investors

US allows use of plasma treatment for COVID patients

US allows use of plasma treatment for COVID patients

Rediff.com24 Aug 2020

The US Food and Drug Administration said on Sunday that over 70,000 patients in the country had been treated with convalescent plasma, which is made using the blood of people who have recovered from coronavirus infections.

US students who took Covaxin, Sputnik asked to get re-vaccinated

US students who took Covaxin, Sputnik asked to get re-vaccinated

Rediff.com4 Jun 2021

These vaccines have not yet been approved by the World Health Organization

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.