Co-Diagnostics revamps COVID-19 test for FDA clearance amid stability concerns
Co-Diagnostics, Inc. has announced that it is withdrawing its 510(k) clearance application for its Co-Dx PCR COVID-19 test following discussions with the Food and Drug ... Read More
Shocking mix-up in tortilla strips puts millions with wheat allergies at risk
Sugar Foods Corporation has announced a recall of its Fresh Gourmet Tortilla Strips Santa Fe Style, citing concerns over an undeclared wheat allergen. The recall ... Read More
FDA shocks Neurotech with rejection of orphan drug status for life-changing PANDAS/PANS treatment
Neurotech International Limited is facing an uphill battle after the United States Food and Drug Administration (FDA) declined the company's request for orphan drug status ... Read More
LifeVantage stock soars on game-changing GLP-1 study results – here’s what you need to know
Shares of LifeVantage Corporation have jumped 8.2% after the company announced encouraging results from a study on its new two-product system designed to boost GLP-1 ... Read More
This new FDA-approved insulin pump just sent Modular Medical’s stock soaring 27%—Find out why!
Shares of Modular Medical, Inc. soared by 27% to reach $2.49, surpassing its previous 52-week high of $2.22, after receiving FDA clearance for its new ... Read More
FDA approves Janssen’s TECVAYLI for multiple myeloma treatment
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration's approval of its first bispecific T-cell engager antibody, ... Read More
Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food and Drug Administration (FDA) for the treatment ... Read More
Lupin Limited launches Generic Suprep Bowel Prep Kit in the US
Indian pharma company Lupin Limited has launched Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, after getting ... Read More
FDA approves Opdivo and Cabometyx combo for advanced kidney cancer treatment
The U.S. Food and Drug Administration (FDA) has officially approved the combination of Bristol Myers Squibb's Opdivo (nivolumab) and Exelixis' Cabometyx (cabozantinib) for the first-line ... Read More
BRILINTA FDA approval: A major step in reducing stroke risks in acute ischemic stroke and high-risk TIA patients
AstraZeneca has secured U.S. Food and Drug Administration (FDA) approval for BRILINTA (ticagrelor), expanding its use to reduce the risk of stroke in patients suffering ... Read More