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US FDA News

28 Mar 2020

US FDA approves five-minute ‘Rapid’ coronavirus COVID-19 test

The company has also been given the US Food and Drug Administration's approval as 'emergency use authorisation' for the test.

14 Nov 2017

In a first, US regulators approve pill that digitally tracks patients' medication intake

Poor compliance with drug regimens is a common problem in many disease areas, especially when patients suffer from chronic conditions.

Sun Pharmaceutical Industries

24 May 2017

US FDA accepts application for psoriasis drug: Sun Pharma

Drug major Sun Pharmaceutical Industries on Wednesday said the US health regulator has accepted biologics licence application (BLA) for tildrakizumab for the treatment of psoriasis.

12 Jul 2016

Coming very soon! Luke prosthetic arm that will change lives of amputees (Watch video)

Previously known as the Deka Arm, the Luke arm - developed by Segway creator Dean Kamen and DARPA (the Defense Advanced Research Projects Agency) - integrates the latest technology in electronics, motors, batteries, and materials.

Dr Reddy's Laboratories

09 Nov 2015

DRL says taking corrective actions after FDA warning letter

DRL shares on Monday stumbled by 3.44 percent over previous close to Rs 3,504.60 on BSE.

Drug firm Unichem Laboratories

16 Oct 2015

Unichem gets USFDA nod for hypertension treatment tablets

Pharmaceutical firm Unichem Laboratories has received US FDA approval for the Losartan Potassium tablets used in treatment of hypertension.

generic drugmaker

25 Mar 2015

IPCA Labs aims to make plants US FDA-compliant by December

IPCA Laboratories Ltd is aiming to make all of its plants facing import alerts from the United States compliant with U.S. Food and Drug Administration (FDA) rules by December, an executive said on Wednesday.

generic drugmaker

25 Mar 2015

IPCA slumps as FDA bans imports from 2 more plants

Shares in generic drugmaker IPCA Laboratories slumped as much 12.7 percent, heading towards their biggest daily fall since July 2014, after the U.S. Food and Drug Administration (FDA) issued an import alert against two of its plants.

18 Mar 2015

US FDA did not find issues with Wockhardt's Chikalthana plant

"The recent inspection at the Aurangabad L1-Chikalthana site was a follow-up inspection by the US FDA as an outcome of completion of good manufacturing practise (GMP) remediation submitted by Wockhardt in October 2014.

31 Jul 2014

FDA raises concern over drug production process at Cadila

The FDA inspected the Moraiya plant, based in Gujarat, in the second week of July.

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