Regulatory
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
The U.S. FDA is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.
The U.S. Centers for Disease Control and Prevention issued a warning that the Delta variant is as infectious as chickenpox and can cause a much more severe COVID-19 infection.
The panels discussed key issues such as expanded access programs (EAPs), clinical trial diversity, conditional approval pathways, and patient experience data.
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.
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