The U.S. Food and Drug Administration (FDA) has approved Amgen’s (NASDAQ:AMGN) KRASG12C inhibitor Lumakras as part of a combination regimen for adults with metastatic colorectal cancer (mCRC) whose tumors harbor an abnormal gene known as KRAS G12C.
Officer of Adaptimmune Therapeutics PLC (NASDAQ:ADAP), executed a sale of 5,584 American Depositary Shares (ADS) on January 17, 2025. The shares were sold at a weighted average price of $0.5808 per share,
AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $207.67 billion and impressive gross profit margins of 82.61%, announced that its drug Calquence (acalabrutinib),
Sage Therapeutics (NASDAQ:SAGE) is reportedly suing Biogen (NASDAQ:BIIB) over enforcement of a standstill agreement in the wake of an unsolicited takeover bid valued at around $469M. The full lawsuit,
AstraZeneca (NASDAQ:AZN) announced Friday that the U.S. FDA approved its Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) with chemoimmunotherapy as a first-line option for adults with mantle cell lymphoma,
Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (SNDX) have received FDA approval for their drug Niktimvo in 9 mg and 22 mg vial sizes. Niktimvo was approved in August 2024 for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg,
This transaction was part of a "Sell to Cover" exercise, automatically implemented to satisfy tax withholding obligations and associated costs. Following this transaction, Mr. Lunger retains ownership of 7,
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 ...
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 (NDA) of CUTX-101,
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics (NASDAQ:SRPT) and Biogen (NASDAQ:BIIB) as examples.
Amid Ionis Pharmaceuticals Inc's (NASDAQ:IONS) challenging year marked by a 38% stock decline and trading near its 52-week low of $31.40, Geary Richard S, Executive Vice President and Chief Development Officer,
Biosciences Inc. (NASDAQ:NBIX), a biopharmaceutical company with robust financials and an "GREAT" health score according to InvestingPro, reported significant stock transactions, according to a recent SEC filing.