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Recent Articles

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Roche's Tina-quant Lp(a) assay receives FDA's Breakthrough Device designation; it measures lipoprotein a levels, a major cardiovascular disease risk factor, affecting one in five people worldwide

Commentary: Law requiring sunscreens to be tested on animals is keeping FDA from approving chemical filters found in world's best sunscreens; bill pending in US House would allow non-animal testing, enable approval of more effective sunscreen ingredients

Pharmaceutical trade associations welcome recognition of EMRN and FDA as WHO Listed Authorities; the recognition expands international cooperation to promote access to safe and quality medical products

Bristol Myers Squibb's subcutaneous Opdivo formulation gets FDA's PDUFA goal date reassigned to December 29, 2024; application based on Phase 3 trial results

FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

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