Regulatory
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.
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).
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
A recent report suggests that cross-contamination is not all that uncommon of an issue, and maybe inevitable.
A vaccine for herpes is under development and Rational Vaccines are going to make this a reality very soon. Here’s everything you need to learn about it.
The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.
Biogen’s Aduhelm was approved on June 7, 2021, for Alzheimer’s patients, and the controversy continues to grow.
Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.
On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
There are two PDUFA dates on the U.S. Food and Drug Administration’s calendar for this week. Here’s a look.
PRESS RELEASES