WILMINGTON, Del. - The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca (NASDAQ:AZN)'s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.

Eli Lilly and Company LLY announced that the FDA has granted approval to its drug, Omvoh (mirikizumab), for its second inflammatory bowel disease (IBD) condition, Crohn's disease (“CD”), in ...

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.

Share prices of Moderna (NASDAQ: MRNA) plummeted 58% in 2024, ranking among the worst performers in the S&P 500 index. The biotech, renowned for its pioneering development of vaccines based on messenger RNA (mRNA),

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,

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),

VLN cigarettes are the first and only combustible tobacco products authorized by the FDA under its Modified Risk ... do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s ...

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 ...

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,

Johnson & Johnson JNJ announced that the FDA has accepted its regulatory filing seeking the FDA’s approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in ...

The FDA's decision is based on promising early data ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...

Rezolute (RZLT) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to ersodetug, RZ358, for the treatment of hypoglycemia due to ...