Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...
Ofatumumab, a fully human anti-CD20 monoclonal antibody, is a disease-modifying therapy (DMT) approved for the treatment of ...
The Noramco Group has announced a $25 million investment to expand its Halo Pharma facility in Whippany, New Jersey, by ...
The FDA approved a prefilled syringe format for Ani's purified Cortrophin Gel that should ease administration for MS patients ...
Celltrion and Formycon with Fresenius Kabi launched their respective ustekinumab biosimilars (Steqeyma and Otulfi), joining 4 ...
The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.
The Noramco Group is investing $25M into its Halo Pharma facility in Whippany, NJ to establish sterile injectable ...
Bacteria navigate tradeoffs between phage resistance and interbacterial competition. This study reveals that while LPS ...
The expansion addresses US injectable capacity shortages and growing demand for reliable domestic sterile manufacturing.
OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable ...
The National Agency for Food and Drug Administration and Control has raised the alarm over the illegal circulation and ...
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