Olympus unit pleads guilty to resolve U.S. duodenoscope probe
(Reuters) – An Olympus Corp subsidiary pleaded guilty on Monday and agreed to pay $85 million to resolve charges that it failed to file reports with U.S. regulators regarding infections…
U.S. regulators snip red tape for medical devices to curb opioid crisis
(Reuters) – Laura Perryman expected her medical company, Stimwave Technologies Inc, would have to wait several years for its painkilling device to win U.S. approval as a treatment for chronic…
Sanofi drug Dupixent wins FDA approval to treat asthma
(Reuters) – France’s Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types…
Insmed’s treatment-resistant lung disease drug gets FDA approval
(Reuters) – The U.S. Food and Drug Administration on Friday approved Insmed Inc’s lead drug to treat a rare, chronic lung disease, making it the first approved treatment in the…
Special Report: Juul copycats flood e-cig market, despite FDA rule
(Reuters) – The sleek Juul electronic cigarettes have become a phenomenon at U.S. high schools, vexing educators and drawing regulatory scrutiny over their sweet flavors and high nicotine content. Now,…
EU approves fifth copy of AbbVie’s $18 billion drug Humira
LONDON (Reuters) – Europe has approved a fifth copy of AbbVie’s $18-billion-a-year biologic drug Humira – the world’s best-selling prescription medicine – ramping up competition among makers of less-expensive biotech…
AstraZeneca plots China robot offensive to counter price cuts
WUXI, China/LONDON (Reuters) – With smart cancer diagnostics, one-stop-shop diabetes kits and AI systems to improve ambulance pick-ups for patients with chest pain, AstraZeneca (AZN.L) aims to move from simply…
U.S. regulator approves Teva migraine drug, shares rise
(Reuters) – Shares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in after-hours trading on Friday after the U.S. Food and Drug Administration (FDA) approved the company’s new…
Merck KGaA, Pfizer’s immuno-drug shown to alleviate kidney cancer
FRANKFURT (Reuters) – Merck KGaA said that its immunotherapy Bavencio, jointly developed with Pfizer, delayed the progression of kidney cancer when used in combination with Pfizer’s Inlyta drug in a…
Israeli radiation therapy firm Alpha Tau raises $29 million
TEL AVIV (Reuters) – Alpha Tau Medical, an Israeli developer of alpha radiation cancer therapy, said on Wednesday it raised $29 million in a private financing round led by private…