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The FDA is offering a four-month grace period to retail and hospital pharmacies that do not act as wholesale distributors to electronically exchange drug transaction information. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
A panel of judges from the Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
The U.S. government and 11 states are seeking as much as $3.3 billion from Novartis over an alleged kickback scheme involving its Exjade and Myfortic drugs, according to documents filed in the U.S. District Court for the Southern District of New York. Read More
The FDA is cracking down on companies that manufacture or distribute unapproved prescription ear drops labeled to relieve pain, infection and inflammation, warning they will be subject to seizures, injunctions and criminal proceedings. Read More
Vertex Pharmaceuticals’ Orkambi has been approved as the first drug intended to treat cystic fibrosis in patients who have two copies of a specific mutation, the FDA announced Friday. Read More
The FDA Thursday told stakeholders at a public hearing that manufacturers of naloxone may switch their products from prescription-only to over-the-counter as long as they can show that it can be used effectively by consumers guided by product labeling alone. Read More
The FDA is investigating the potential risks of medicines containing codeine to treat coughs and colds in children 18 and younger because of the potential for serious side effects, according to a safety announcement released Wednesday. Read More
Gilead Sciences has submitted an NDA for a once-daily single tablet regimen to treat HIV-1 infection in adult and pediatric patients 12 years and older, using a priority review voucher that it acquired from Knight Pharmaceuticals for $125 million in November 2014. Read More
Galderma has received FDA approval for its injectable gel Restylane Lyft with lidocaine to correct age-related volume loss in the cheek area for people over 21, offering a nonsurgical option to help restore cheek fullness. Read More