News for 'FDA'

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.

Pfizer withheld Covid vaccine news before elections: Trump

Pfizer withheld Covid vaccine news before elections: Trump

Rediff.com10 Nov 2020

Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine.

Trials find Covid vax safe for kids aged 5-11 yrs: Pfizer, BioNTech

Trials find Covid vax safe for kids aged 5-11 yrs: Pfizer, BioNTech

Rediff.com20 Sep 2021

Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.

US sets new record with over 3,000 COVID deaths in 1 day

US sets new record with over 3,000 COVID deaths in 1 day

Rediff.com10 Dec 2020

The previous single-day record was on May 7 at 2,769 deaths.

US eases travel advisory for India

US eases travel advisory for India

Rediff.com17 Aug 2021

The new travel advisory came in the wake of the significant improvement in Covid situation in India.

US lifts Covid curbs on fully-vaccinated travellers from Nov 8

US lifts Covid curbs on fully-vaccinated travellers from Nov 8

Rediff.com26 Oct 2021

The US will lift all restrictions for fully vaccinated international travellers, including from India, from November 8 but they will have to show proof of a negative coronavirus test before boarding a flight to the country, the White House has announced.

Ferrari wants women drivers for its motor racing academy

Ferrari wants women drivers for its motor racing academy

Rediff.com13 Dec 2019

Ferrari are planning to add female racers to their expanding young driver programme as they seek to develop talent for the future.

Travel restrictions imposed after 1st coronavirus death in US

Travel restrictions imposed after 1st coronavirus death in US

Rediff.com1 Mar 2020

Vice President Mike Pence said Trump had authorised a ban on entry of foreign nationals who travelled to Iran in the last 14 days. The United States also advised its citizens not to travel to parts of South Korea and Italy, from where reports of coronavirus have appeared.

Schumi Jr's dream comes true as he takes first step on F1 journey

Schumi Jr's dream comes true as he takes first step on F1 journey

Rediff.com2 Dec 2020

Mick Schumacher, who will face intense scrutiny as embarks on his Formula One career, said for now he was simply overwhelmed to be following in his father's footsteps and called his promotion a dream come true.

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.

Madhuri Dixit gets FDA notice for endorsing Maggi

Madhuri Dixit gets FDA notice for endorsing Maggi

Rediff.com29 May 2015

If the actress fails to respond to the notice within the stipulated time frame, a case could be registered against her, Food Security Officer Mahimanand Joshi said.

Cadila gets tentative FDA nod

Cadila gets tentative FDA nod

Rediff.com15 Jun 2006

Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.

Pfizer moves US court against Aurobindo, Dr Reddy's over cancer drug

Pfizer moves US court against Aurobindo, Dr Reddy's over cancer drug

Rediff.com17 Nov 2020

Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.

'Red Bull' under FDA lens

'Red Bull' under FDA lens

Rediff.com13 Jul 2005

Maharashtra Food and Drug Administration has prohibited the sales of 'Red Bull', an energy drink, following complaints that the product's main ingredient Taurine is an animal derivative, which the company denies saying it is derived sythetically.

FDA diktat on 'wonder' drugs

FDA diktat on 'wonder' drugs

Rediff.com20 Apr 2005

Alarmed by the growing number of advertisements on 'miracle' drugs being shown on television channels, Maharashtra Food and Drug Administration

Ranbaxy drug gets FDA nod

Ranbaxy drug gets FDA nod

Rediff.com1 Feb 2005

Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.

FDA cracks down on Bisleri

FDA cracks down on Bisleri

Rediff.com25 Oct 2004

The Maharashtra Food and Drug Administration on Monday ordered Parle Bisleri, manufacturer of Bisleri mineral water to stop production in its two units in Mumbai with immediate effect.

An Indian American in the White House?

An Indian American in the White House?

Rediff.com13 Mar 2023

What would an Indian American president of the US look like, sound like and act like, especially on issues and policies pertaining to his or her 'mother-land'?, asks N Sathiya Moorthy.

A bitter pill for Aurobindo's sterile drug unit

A bitter pill for Aurobindo's sterile drug unit

Rediff.com25 Nov 2019

USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.

4 Indian drug firms recall products in US market

4 Indian drug firms recall products in US market

Rediff.com15 Nov 2020

Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.

Sterilisation botch-up: FDA seals drug unit in Raipur

Sterilisation botch-up: FDA seals drug unit in Raipur

Rediff.com13 Nov 2014

The drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.

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

Ranbaxy gets FDA nod for Topiramate

Ranbaxy gets FDA nod for Topiramate

Rediff.com17 Dec 2004

Pharma major Ranbaxy Laboratories Ltd on Friday said it has received tentative approval from the US Food and Drug Administration to manufacture and market 25 mg, 100 mg and 200 mg Topiramate tablets.

Ranbaxy gets FDA nod for drugs

Ranbaxy gets FDA nod for drugs

Rediff.com9 Sep 2004

Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths

Daiichi, Ranbaxy team to counter FDA charges

Daiichi, Ranbaxy team to counter FDA charges

Rediff.com27 Feb 2009

The USFDA has accused Ranbaxy of falsifying data and test results of medicines. A Daiichi Sankyo statement said it takes the issue very seriously. 'Both Daiichi and Ranbaxy have formed a team to solve the issue. Ranbaxy will be responding to the FDA and will continue to cooperate with the agency.' Ranbaxy shares fell more than 18 per cent to Rs 169.85 today on the Bombay Stock Exchange, while Daiichi stock dropped about 10 per cent to yen 1,680 on the Tokyo Stock Exchange.

Ranbaxy gets FDA nod for Modafinil

Ranbaxy gets FDA nod for Modafinil

Rediff.com23 Feb 2004

Ranbaxy Laboratories said on Monday that it has received tentative approval from the US Food and Drug Administration to manufacture and market Modafinil tablets, a generic of Cepahalon's Provigil.

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.

Ranbaxy gets FDA nod for Amoxicillin

Ranbaxy gets FDA nod for Amoxicillin

Rediff.com8 Dec 2003

Ranbaxy Laboratories on Monday said it has received final approval from the United States Food and Drugs Administration to manufacture and market Amoxicillin and Clavulnate Potassium tablets, a generic version of GlaxoSmithkline's Augmentin.

USFDA raises concern over drug production process at Cadila

USFDA raises concern over drug production process at Cadila

Rediff.com31 Jul 2014

Sources say FDA letter over product and not entire facility

Ranbaxy gets FDA nod for Metformin

Ranbaxy gets FDA nod for Metformin

Rediff.com12 Sep 2003

Ranbaxy Laboratories on Friday said it had received the United States Food and Drug Administration approval to manufacture and market Metformin HCL oral solution, a drug used by the diabetic patients.

Ranbaxy gets FDA nod for Loratidine

Ranbaxy gets FDA nod for Loratidine

Rediff.com21 Aug 2003

Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine

Dr Reddy's sued in US court by S Korean pharma co

Dr Reddy's sued in US court by S Korean pharma co

Rediff.com27 Jan 2017

Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.

Sklamberg on challenges the US drug regulator faces globally

Sklamberg on challenges the US drug regulator faces globally

Rediff.com19 Mar 2015

The US Food and Drug Administration (FDA) says it does not follow an India agenda.

US food regulator testing Maggi noodles after India recall

US food regulator testing Maggi noodles after India recall

Rediff.com11 Jun 2015

Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.

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.

Dilip Shangvi down Rs 90,840 crores in two years!

Dilip Shangvi down Rs 90,840 crores in two years!

Rediff.com8 Jun 2017

An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.

US eases travel recommendations on India as Covid cases fall

US eases travel recommendations on India as Covid cases fall

Rediff.com20 Jul 2021

When last month's advisory was issued, India was struggling with a second wave of the pandemic with more than 3,00,000 daily new coronavirus cases being reported.

Anti-malarial drug a 'line of defence' against virus: Trump

Anti-malarial drug a 'line of defence' against virus: Trump

Rediff.com20 May 2020

The US president said the drug has gotten a bad reputation only because 'he was promoting it'.

India can deliver COVID-19 vaccine swiftly and efficiently

India can deliver COVID-19 vaccine swiftly and efficiently

Rediff.com4 Jan 2021

'Rolling out the vaccine is not a major challenge in India.'

India raises concerns over FDA actions on domestic drug firms

India raises concerns over FDA actions on domestic drug firms

Rediff.com10 Feb 2014

India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.