On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, ...
The novel formulation of rizatriptan and meloxicam (Symbravo, Axome Therapeutics) is for the acute treatment of migraine with ...
The approval of Axsome Therapeutics’ Symbravo for migraine with or without aura came alongside the greenlight for Vertex's ...
Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...
NeurAxis offers FDA-cleared IB-Stim device for pediatric IBS pain. Despite positive advancements, market recognition lags.
Interesting Engineering on MSN1d
Breakthrough: US FDA clears first gene-edited pig kidney transplants in humansIn a significant development for organ transplantation, two U.S. biotechnology companies, United Therapeutics and ...
GlobalData on MSN4d
EssilorLuxottica wins FDA clearance and EU approval for OTC audio glassesEssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...
It’s not cleared for chronic pain. “Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, MD, acting director of the FDA’s ...
Vertex has attracted interest from Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple ... certain semiautomatic rifles clears Senate committee in first ...
Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive ...
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