News for 'FDA'

Hydroxychloroquine doesn't help treat COVID-19: Report

Hydroxychloroquine doesn't help treat COVID-19: Report

Rediff.com22 Apr 2020

Trump has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients.

Study Abroad: Uncertainty over Vaccination

Study Abroad: Uncertainty over Vaccination

Rediff.com14 Jun 2021

With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.

Why Sun Pharma stock will remain under pressure

Why Sun Pharma stock will remain under pressure

Rediff.com24 Dec 2019

The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.

Local drug makers worried as regulators start working together

Local drug makers worried as regulators start working together

Rediff.com26 Dec 2013

Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.

It's a tough road ahead for pharma companies

It's a tough road ahead for pharma companies

Rediff.com29 May 2013

Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.

US drug regulator warns RPG Life Sciences

US drug regulator warns RPG Life Sciences

Rediff.com19 Jun 2013

The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.

Why Dr Reddy's expects FY19 to be stronger and richer

Why Dr Reddy's expects FY19 to be stronger and richer

Rediff.com6 Mar 2018

The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015

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.

Covid vaccine boosters not appropriate at this stage: Lancet study

Covid vaccine boosters not appropriate at this stage: Lancet study

Rediff.com13 Sep 2021

The results reported from the observational studies, on average, show that vaccination had 95 per cent efficacy against severe disease both from the Delta variant and from the Alpha variant, and over 80 per cent efficacy at protecting against any infection from these variants.

Lupin recalls 9,210 bottles of anti-infective drug from the US

Lupin recalls 9,210 bottles of anti-infective drug from the US

Rediff.com15 Apr 2014

The recent recalls come amid increased FDA scrutiny of medicines produced in India.

J&J licence to make cosmetics at Mulund plant cancelled

J&J licence to make cosmetics at Mulund plant cancelled

Rediff.com25 Jun 2013

The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.

COVID-19 vaccine unlikely before Fall of 2021: Experts

COVID-19 vaccine unlikely before Fall of 2021: Experts

Rediff.com2 Oct 2020

Researchers at McGill University in Canada carried out a survey of 28 experts working in vaccinology in late June 2020. The majority of those surveyed were mostly Canadian or American academics with an average of 25 years of experience working in the field.

Travel firms expect heavy rush as US lifts curbs

Travel firms expect heavy rush as US lifts curbs

Rediff.com18 Oct 2021

Travel companies are expecting a heavy rush to the US following the withdrawal of curbs on fully vaccinated travellers from select countries, including India, on November 8. The move will benefit those holding long-term tourist, business, and work visas. Also, new and extra flights by Air India and American Airlines are expected to provide better travel options.

Why investors are regretting giving Gland Pharma IPO a miss

Why investors are regretting giving Gland Pharma IPO a miss

Rediff.com24 Nov 2020

Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.

Novovax Covid vaccine likely to get nod in India ahead of US

Novovax Covid vaccine likely to get nod in India ahead of US

Rediff.com18 Aug 2021

Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.

Zika epidemic: Donated blood across US to be screened for virus

Zika epidemic: Donated blood across US to be screened for virus

Rediff.com28 Aug 2016

The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.

Ranbaxy whistle-blower to talk on quality of Made-in-India drugs

Ranbaxy whistle-blower to talk on quality of Made-in-India drugs

Rediff.com27 Feb 2014

Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.

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.

After ban on drug facilities, US regulator comes calling

After ban on drug facilities, US regulator comes calling

Rediff.com10 Feb 2014

Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.

'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.'

Your toothpaste can fight lung disease

Your toothpaste can fight lung disease

Rediff.com21 May 2018

A common antibacterial substance found in toothpaste may combat life-threatening diseases such as cystic fibrosis, or CF, when combined with an already FDA-approved drug.

Dr Reddy's files with US FDA for generic Zofran

Dr Reddy's files with US FDA for generic Zofran

Rediff.com8 May 2003

Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n

After a year, Aurobindo Pharma starts getting USFDA nod

After a year, Aurobindo Pharma starts getting USFDA nod

Rediff.com4 Jun 2012

Both the units were under the scanner of FDA since 2011.

BJP leaders want re-election in Maharashtra

BJP leaders want re-election in Maharashtra

Rediff.com4 Nov 2019

'Many of them are angry as we could not contest in some seats due to pact with the Sena and lost with a thin margin in some segments'

Ranbaxy woes continue to dog Sun Pharma

Ranbaxy woes continue to dog Sun Pharma

Rediff.com29 Oct 2015

The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.

3 Indian firms get FDA nod for sleep disorder drug

3 Indian firms get FDA nod for sleep disorder drug

Rediff.com26 Apr 2007

Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi

Hydroxychloroquine can be fatal: Experts

Hydroxychloroquine can be fatal: Experts

Rediff.com6 May 2020

As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.

Cipla gets nod to import Moderna vaccine for emergency use in India

Cipla gets nod to import Moderna vaccine for emergency use in India

Rediff.com29 Jun 2021

India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.

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.

No sabotage at Toansa plant, says Ranbaxy

No sabotage at Toansa plant, says Ranbaxy

Rediff.com12 Feb 2014

Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.

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

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.

Can You SAVE This Mother's Life?

Can You SAVE This Mother's Life?

Rediff.com2 Aug 2022

'As a donor, you may think you are saving one life. But you touch the lives of the entire family and community associated with the person. And it only cost you a few hours of your life.'

Boxing great Mike Tyson advocates for psychedelics

Boxing great Mike Tyson advocates for psychedelics

Rediff.com29 May 2021

Tyson said he wants to spread word of the benefits of psilocybin as widely as possible, which is why he has partnered with Wesana.

Ranbaxy gets US nod to sell Alzheimer's generic

Ranbaxy gets US nod to sell Alzheimer's generic

Rediff.com22 Sep 2010

India's largest drugmaker, Ranbaxy, will have an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug for Alzheimer's in the US.

FDA import ban: R'bxy hires ex-NY Mayor as advisor

FDA import ban: R'bxy hires ex-NY Mayor as advisor

Rediff.com18 Sep 2008

The US Food and Drug Administration has issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India. Giuliani, a high-profile Republican leader and former US attorney in Manhattan, would provide advice and review compliance issues. Ranbaxy has been accused of selling generic drugs which did not meet FDA standards.

Safety concerns over Maggi noodles back to haunt Nestle

Safety concerns over Maggi noodles back to haunt Nestle

Rediff.com30 Nov 2017

This time food regulators found excess presence of ash content in Maggi