Regulatory

Here’s a look at Pfizer-BioNTech, Novavax and the COVID-19 vaccine’s sales, approval in children, additional trials, potential of booster shots, and more.
The U.S. FDA cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.
Pfizer reported its first-quarter 2021 revenues of $14.6 billion, an impressive 42% operational growth.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 4, 2021.
FDA
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.
This drug is made and manufactured by ViiV Healthcare and is a combination of cabotegravir and rilpivirine.
AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth.
The U.S. FDA’s Oncologic Drugs Advisory Committee did not agree in a recent meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
A study found in India that the existing COVID-19 vaccines should be effective against the Indian variant, not just the Pfizer-BioNTech vaccine.
An investigational Alzheimer’s disease drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.
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