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The FDA has cleared Bristol-Myers Squibb’s new mixed-drug regimen for the treatment of advanced melanoma, in a first-ever approval of an immune-oncology combination. Read More
Teva is expanding its footprint in emerging markets with the $2.3 billion purchase of Mexico-based Representaciones e Investigaciones Medicas, or Rimsa, a specialty drugmaker with a portfolio of products and patents across Latin America. Read More
United Therapeutics has agreed to grant Sandoz a nonexclusive license to manufacture and sell a generic version of its hypertension drug Remodulin beginning in 2018, putting an end to ongoing patent litigation. Read More
Eli Lilly and Incyte’s new once-daily rheumatoid arthritis drug baricitinib outperformed the standard care in a Phase 3 clinical trial, putting the drugmakers on track for a regulatory filing this year. Read More
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
New Hampshire’s attorney general is investigating whether some opioid manufacturers knowingly misled doctors and patients about their drugs’ safety and benefits, causing the state to pay for potentially dangerous and unnecessary opioid prescriptions. Read More
President Barack Obama late Wednesday was expected to sign a measure to fund the federal government at fiscal year 2015 levels through Dec. 11, thereby averting a government shutdown. Read More
Despite having been closed for more than a year with no plan to reopen, the FDA issued a warning letter to Specialty Medicine Compounding Pharmacy for a litany of cGMP violations, including poor sterile processing controls. Read More
Despite its lucrative promise, the FDA’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More