Nearly 20 percent of American adolescents, or one in five, has suffered a concussion, according to newly released statistics.
Researchers have discovered a protein that could help diagnose a degenerative brain disease commonly found in athletes, veterans of military service and others who have experienced brain trauma.
Digital devices designed to monitor the wearer’s health in much greater detail than current models will need regulatory approval, and Apple Inc., Fitbit Inc. and seven other companies will take part in a program to speed the approval process, the U.S. health regulator said.
PTC Therapeutics Inc. failed to supply persuasive evidence that its experimental drug to treat a form of Duchenne muscular dystrophy is effective, the U.S. Food and Drug Administration said, dealing a blow to the company’s years-long effort to bring the drug to market.
Europe’s drugs regulator could lose more than 70 percent of staff, making it unable to function, if politicians pick the wrong new home for the London-based agency, it warned on Tuesday.
Drug developer Axovant Sciences Ltd. said it would stop testing the company’s lead drug in Alzheimer’s after it failed to meet the main goals of a late-stage trial.
New Novartis Chief Executive Officer Vasant Narasimhan has a goal of saving 25 percent of clinical trial costs by using digital technology.
Genocea Biosciences is pivoting a development strategy to focus on development of neoantigen cancer treatments and scrapping its Phase III-ready herpes drug.
By Susan Cornwell, Yasmeen Abutaleb WASHINGTON (Reuters) – U.S. Senator Susan Collins rebuffed intense lobbying from fellow Republicans and the promise of money for her state in deciding on Monday to oppose – and likely doom – her party’s last-ditch effort to repeal Obamacare. The most moderate of Republican senators joined John McCain […]
Authorities from a record 123 countries, including the U.S. FDA, have taken action against hundreds of businesses suspected of illegally selling medicines over the internet, officials said.
The FDA declined to approve Intellipharmaceutics International ‘s long-acting opioid painkiller in its current form.
The U.S. FDA issued a Complete Response Letter calling for additional clinical data to evaluate the safety of Janssen’s rheumatoid arthritis drug sirukumab.
Pfizer launched a six-person biotech startup, SpringWorks Therapeutics, with a $103 million Series A financing. Joining Pfizer in funding the company was Bain Capital Life Sciences, Bain Capital Double Impact, OrbiMed and LifeArc, formerly known as MRC Technology.
PureTech subsidiary Gelesis is moving closer to filing for regulatory approval of its obesity treatment Gelesis100 after results of the latest study, the company said.
U.S. senators made a last-ditch effort to secure support for the latest Republican attempt to repeal former President Barack Obama’s signature healthcare law, releasing revised legislation to appeal to undecided senators.
Roche immunotherapy Tecentriq won European Union approval for treating advanced lung and bladder cancer, the Swiss drugmaker said.
A Native American tribe holding patents for drugmaker Allergan Plc moved to dismiss a case brought by generic drug company Mylan NV challenging the patents.
Versartis Inc. said the company’s experimental human growth hormone somavaratan failed to meet endpoints in a critical Phase III trial.
Japan will weigh the concerns of U.S. drug firms in its efforts to complete by year-end a drastic revision of its drug-pricing system, aimed at reining in medical spending and cutting the public burden, the health minister said.
Federal lawmakers are concerned that a recent cyberattack on pharma giant Merck & Co. could lead to numerous problems. including a drug shortage.