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Blog Posts by Mark Rubinshtein, Ph.D.

Delaware Court Denies Preliminary Injunction Seeking To Block Liquidia’s YUTREPIA Launch
The United States District Court for the District of Delaware recently denied United Therapeutics Corporation‘s motion for a preliminary injunction.  The motion sought to prevent Liquidia Technologies, Inc. from launching...
First At-Home Artificial Insemination Kit Receives FDA Clearance
Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit.  The kit was developed for those who...
FDA Approves Neuralink to Begin Human Trials of Brain Implants
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device.  Recruitment...
BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda
Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda.  According to BioNTech’s press release, the...
U.S. FDA Approves Monkeypox Treatment Formulation
By Mark Rubinshtein (May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of...
Two Drugs Recalled Due to Manufacturing Issues
By Mark Rubinshtein (December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. Edge...
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