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Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than is provided in a related House bill. Read More
Chicago-based Durata Therapeutics won FDA approval for Dalvance, an antibacterial for skin infections that is the first drug approved under the Qualified Infections Disease Product designation, the agency said Friday. Read More
Two California counties sued five drugmakers, alleging they improperly promoted addictive painkillers for chronic pain management, the latest localities to target opioid manufacturers as a way to combat abuse. Read More
A Las Vegas jury has found Takeda Pharmaceutical not liable for the bladder cancer of two women who took the Japanese drugmaker’s diabetes drug Actos, marking the firm’s fifth legal victory out of six cases that have gone to trial so far. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said Thursday. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
Another compounding pharmacy has received an FDA warning for actions that occurred prior to passage of a new law that boosted the agency’s authority over such facilities. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. Read More
Manufacturers that are slow to report overpayments for drugs reimbursed through federal healthcare programs, such as Medicare or Medicaid, could face fines of $10,000 a day, under a proposed regulation — a rule that could cause major headaches for drugmakers trying to sort out complex government billing systems. Read More