Without FDA approval, no drug or medical device can access what is by some distance the world’s largest market for pharma and medtech. Photograph: Roel Smart/Getty Images/iStockphoto

In what was truly a case of David vs Goliath, Irish pharma minnow Amarin comprehensively saw off the might of the US drug regulator, the Food and Drug(...)

Amarin chief executive and president  John Thero. Photograph: Cyril Byrne / THE IRISH TIMES

A small one-product Irish pharmaceutical company has secured a landmark victory over the US drugs regulator in a New York court. US district ju(...)

Janet Woodcock, FDA director of the agency’s Center for Drug Evaluation and Research: Amarin has taken a pre-emptive First Amendment case, accusing the FDA of restricting its right to free speech

The US Food and Drug Administration seems mildly discomfited. It’s not a state that one usually associates with the most powerful regulator of the pha(...)

Amarin chief executive John Thero: Irish pharma group is suing US regulator FDA over first amendment rights. Photograph: Cyril Byrne / THE IRISH TIMES

Drugmakers have long argued they should have the right to talk to doctors about unapproved uses for their products, as long as they are being truthful(...)

Irish pharmaceuticals group Amarin has secured $52.8 million in new capital through the placement of shares with new and existing investors.The compan(...)

Out Wednesday: Abercrombie & Fitch results
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TODAY Results: FBD; Sotheby’s; Thorntons. Indicators: Euro zone CPI (Feb) and unemployment rate (Jan); US ISM manufacturing PMI (Feb), ISM prices paid(...)

Amarin told the market the US Food and Drug Administration’s office of new drugs had denied its appeal of the decision to withdraw approval of its Anchor clinical trial, designed to expand its market for Vascepa by including patients with lower but still elevated levels of blood fats.

Shares in Irish pharmaceuticals group Amarin slumped more than 20 per cent yesterday as the US regulator shut the door on the company’s plans to exten(...)

John Thero, Amarin chief executive. Photograph: Cyril Byrne / The Irish Times

Amarin has today asked a federal court to order the US Food and Drug Administration to give the company’s Vascepa fish oil pill five years of (...)

Advisers to the Food and Drug Administration had in October recommended that the agency not approve Vascepa for the new use until the larger 8,000-patient trial shows that lowering blood fats leads to reduced cardiovascular risk. The Irish drugmaker said it planned to appeal the decision.

Shares in Irish drugmaker Amarin haver fallen almost 30 per cent in two days after US health regulators rejected a preset testing process that was cri(...)

 Aer Lingus has added Pula to its destinations, bringing the Istrian peninsula and pretty towns such as Porec within easy reach for short breaks and holidays
Ask Joan

We have travelled to Dubrovnik and surrounding Islands for the last seven years. We love it but find it getting increasingly more expensive. I see Aer(...)