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Teva Pharmaceutical is voluntarily scratching all sales, marketing and distribution for its migraine patch Zecuity, following a stream of reports linking the patch to burns and permanent scarring. Read More
Drugmakers seeking approval of osteoporosis candidates should bolster their submissions with nonclinical pharmacology studies to determine adverse effects, the FDA advises. Read More
Two Indian drugmakers risk losing their EU marketing certificates this month after regulators in France and Croatia turned up a multitude of GMP violations. Read More
The FDA has slapped Polydrug Laboratories’ Mumbai facility with a warning letter for alleged GMP deviations seven months after it received a ban on U.S. imports. Read More
Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Read More
The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Read More