Phase III
The company is eager to diversify, putting Phase II clinical trials in sickle-cell disease, beta-thalassemia, kidney diseases, and pain management.
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company’s chronic kidney disease drug, tenapanor.
As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.
AstraZeneca said in an earnings announcement on Thursday it will seek authorization for its COVID-19 vaccine in the U.S. sometime in the second half of this year.
The FDA Watch List considers drug-resistant Candida auris (C. auris) an urgent threat, drug-resistant Candida species a serious threat, and azole-resistant Aspergillus Fumigatus worth watching – especially since person-to-person transmission of drug-resistant fungi has been recently documented.
The company’s pipeline was strengthened in the second quarter with three strategic collaborations in immuno-oncology, immuno-neurology, and HIV.
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
Moderna continues to assess its COVID-19 vaccine in juveniles, the company is expanding the study to include protocols to detect the potential of rare side effects, including heart inflammation.
Merck’s Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
Today is the first day of the Alzheimer’s Association International Conference 2021 (AAIC), behind held both virtually and in person in Denver, Colorado. Here’s a look at some of today’s stories.
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