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Pfizer suffered a setback Tuesday in its efforts to defend itself against charges that a division of the company illegally slowed generic competition for one of its products. Read More
The FDA has approved Japanese drugmaker Takeda Pharmaceutical’s biologic injection Entyvio to treat adults with moderate to severe ulcerative colitis or Crohn’s disease. Read More
The FDA is developing mathematical algorithms that will compare generic drugs to their branded counterparts, according to an agency grant announcement. 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
The FDA has issued a warning letter to Sanum-Kehlbeck for using the same equipment to produce penicillin and non-penicillin products and other quality violations. Read More
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 a related House bill. 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
Stronger public-private partnerships, a streamlined clinical trials process, more funding for the FDA and beefed up safeguards on intellectual property are some of the ways to improve drug innovation, experts from government and industry said yesterday. Read More
Swiss drugmaker Novartis said it would give New York City-based Ophthotech Corp. up to $1 billion to license its experimental eye drug Fovista outside of the U.S. Read More