Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective ...
an immunotherapy drug that targets and kills cancerous B cells. Both are given through an IV and were approved by the FDA in 2008 and 1997, respectively. A clinical trial, involving 598 patients ...
The approval was based on results from the phase 3 REVISIT trial. The FDA has approved the intravenous antibiotic Emblaveo for adults with complicated intra-abdominal infections who have limited ...
The FDA is reviewing the application for bentracimab for use as a ticagrelor reversal agent in patients with uncontrolled bleeding or in those who require urgent surgery or invasive procedure.
On April 4 (local time), the U.S. Food and Drug Administration (FDA) approved Onapgo ... Medytox launches new botulinum toxin line at international aesthetic surgery conference Medytox announced ...
In a significant advancement in hearing and vision solutions, EssilorLuxottica has announced that its Nuance Audio Glasses have gained clearance from the Food and Drug Administration (FDA ...
Findings showed tocilizumab-anoh had comparable efficacy, pharmacokinetics, safety, and immunogenicity with Actemra. The Food and Drug Administration (FDA) has approved Avtozma ® (tocilizumab-anoh), a ...
The US Food and Drug Administration (FDA) has approved Supernus Pharmaceuticals’ Onapgo (apomorphine hydrochloride) injection to treat motor fluctuations in adults with advanced Parkinson’s disease ...
The Nuance Audio smart glasses designed to help those with hearing loss have gained FDA approval, meaning they can be explicitly sold OTC in the US for that purpose. The EssilorLuxottica brand’s ...
Two US biotech companies say the Food and Drug Administration has cleared them to conduct clinical trials of their ... Meanwhile, rival eGenesis said it had received FDA approval in December for a ...
4, 2025 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step ...
Then, in 2022, the FDA shut down the company’s second approval bid with a complete response letter requesting more information on the drug's labeling, manufacturing and other factors ...