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The FDA is allowing certain biologic products to carry stand-alone symbols on labels, in an effort to harmonize requirements with EU standards. Read More
The U.S. Supreme Court has paved the way for the possibility of drugmakers collecting enhanced damages in patent cases, striking down an appellate standard in a unanimous 8-0 decision. Read More
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