Amgen wins FDA nod for Lumakras as a drug combo for colorectal cancer
The U.S. Food and Drug Administration (FDA) has approved Amgen’s (NASDAQ:AMGN) KRASG12C inhibitor Lumakras as part of a ...
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Here's How Donald Trump Could Shake Up Health Care — And Biotech Stocks
Biotech stocks have slumped 15% since Donald Trump won his second presidency. That's because Trump comes with a lot of ...
FDA Authorizes All ZYN Nicotine Pouch Products Marketed By Swedish Match In U.S.
The U.S. Food and Drug Administration has authorized all ZYN Nicotine Pouch Products Currently Marketed by Swedish Match, a ...
Incyte, Syndax get FDA okay for 9 mg, 22 mg Niktimvo vials
Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (SNDX) have received FDA approval for their drug Niktimvo in 9 mg and 22 mg ...
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Top 5 Small-cap Pharma Stocks (Updated January 2025)
Today's pharmaceutical market is facing the challenges of inflation, government-imposed drug price caps and waning demand for ...
FDA proposes plan to make cigarettes ‘nonaddictive’ by limiting tobacco
The U.S. Food and Drug Administration has issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco ...
Arrowhead says FDA accepts NDA for investigational plozasiran
Pharmaceuticals announced that the U.S. FDA has accepted the New Drug Application for investigational plozasiran for the ...
AstraZeneca's Calquence gains FDA nod for 1L MCL treatment
AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $207.67 billion and ...
FDA bans use of Red No. 3 artificial coloring
The Food and Drug Administration announced it is banning the use of Red No. 3, a synthetic dye used in thousands of foods, including candy and ...
FDA extends review of Fortress Biotech's CUTX-101 drug
Fortress Biotech, Inc. (NASDAQ:FBIO), a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has extended the target action date for the New Drug Application ...
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FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV Vaccines Abrysvo And Arexvy
(RTTNews) - The FDA has required the manufacturers of the ... opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...
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Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...