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The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal ...
Amgen (AMGN) announced that the U.S. FDA has approved Lumakras in combination with Vectibix for the treatment of adult patients with KRAS ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
Eli Lilly said on Wednesday the U.S. health regulator has approved its drug to treat adults with moderate-to-severe Crohn's ...
Jan. 16 (UPI) --The U.S. Food and Drug Administration on Thursday approved the marketing of Zyn nicotine pouch products after undertaking an extensive scientific review of them. The American Lung ...
INNOVATE Corp. (VATE) announced that the U.S. FDA has approved the MediBeacon TGFR for the assessment of kidney function in patients with ...
(RTTNews) - Incyte (INCY) and Syndax Pharmaceuticals (SNDX) announced that the U.S. Food and Drug Administration has approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes. The Companies ...
The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a thorough review." These nicotine pouches are small fiber pouches ...
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...