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US FDA accepts application for psoriasis drug: Sun Pharma

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.

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

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.  

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.

Unichem gets USFDA nod for hypertension treatment tablets

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.

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.

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.

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.

FDA raises concern over drug production process at Cadila

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

FDA bans imports from Canadian drugmaker Apotex's India plant

The U.S. Food and Drug Administration banned imports from Canadian drugmaker Apotex Inc`s manufacturing plant in India for not complying with quality standards, the latest in a series of sanctions against medicines produced in India.

Sun Pharma gets FDA import ban on Gujarat plant

The plant in Karkhadi in Gujarat makes both drug ingredients and formulations, according to Sun`s 2013 annual report.

US bans bidis made by Indian tobacco company

US regulators Friday banned the sale and import of small cigarettes known as bidis made by an Indian company, their first such action since being given oversight of tobacco products in 2009.

Sensex falls over 200 points, Ranbaxy slumps nearly 20%

Sensex slipped by over 200 points in the late morning trade to fall further from its record closing high pulled down by shares of Ranbaxy which fell about 20 percent following the banned of products by US FDA.

Ranbaxy falls around 16% after FDA bans products

Shares in Ranbaxy Laboratories Ltd, majority owned by Japan`s Daiichi Sankyo Co Ltd, slumped around 16 percent in early trade after the US Food and Drug Administration banned more products from the Indian drugmaker.

Ranbaxy Laboratories hit again as US FDA bans more products

In a setback to Indian pharmaceutical giant Ranbaxy, the US has prohibited the company from producing and distributing drugs for the American market from its Toansa facility in Punjab.

Drugmakers urge FDA security audit after cyber breach

The US Food and Drug Administration is under pressure from the pharmaceutical industry and lawmakers to undergo an independent security audit, after hackers broke into a computer system used by healthcare companies to submit information to the agency.

US FDA for greater freedom to generic cos in product labelling

Generic manufacturers, which make cheaper but therapeutically equivalent versions of innovative drugs, would be required to inform the brand name manufacturer about the labelling change.

Ranbaxy falls about 30% after FDA import alert

A third Ranbaxy Laboratories plant in India has been sanctioned with an import alert ban from the US Food and Drug Administration, triggering the worst single day fall in its stock on Monday and a brokerage downgrade.

US to hike fees for generic drugmakers; Indian firms to be hit

Many Indian drugmakers will soon have to bear higher costs for sale of products in American markets, as the US health regulator FDA is hiking the fees for generic drugmakers by up to 48 percent from October.

US FDA asks Indian drugmakers to comply or face action

The US Food and Drug Administration (FDA) also warned of "appropriate action" against the companies who fail to implement "Good Manufacturing Practices".

Lupin awaits FDA approval to launch over 100 drugs in US

The company had filed 25 abbreviated new drug applications (ANDAs) with the US FDA last fiscal thereby taking the total number of total filings to 176 so far.