The FDA on Monday approved a new drug for patients with advanced small cell lung cancer, permitting the treatment to be marketed based on less evidence than it traditionally requires in order to speed its path to market.
Madrid-based PharmaMar, which... Read more »
The FDA on Monday revoked its emergency authorization permitting use of the antimalarial drugs hydroxychloroquine and chloroquine to treat the novel coronavirus, citing a lack of evidence of their efficacy.
In late March the agency authorized the drugs, which President Donald... Read more »
At the start of 2020 thousands of biotechies anticipated spending the second week of June in San Diego, hobnobbing at the annual conference hosted by the Biotechnology Innovation Organization.
Instead, attendees from 64 countries spanning 28 times zones convened online this week... Read more »
Reata Pharmaceuticals is readying its lead drug, a potential treatment for a rare, genetic form of chronic kidney disease called Alport syndrome, for an FDA filing this year. New York private equity giant Blackstone Group, via its newly flush life sciences... Read more »
Less than a month after reporting preliminary early-stage data for its experimental vaccine for the novel coronavirus, Moderna has finalized the plan for a Phase 3 test.
The study, set to begin next month, is targeting enrollment of about 30,000 volunteers,... Read more »
Verve Therapeutics aims to use gene editing to address heart attacks by targeting the liver, not the heart. And it wants to make its edits inside the patient. The startup’s approach raises a lot of questions. Verve has some answers now,... Read more »
Merck’s blockbuster cancer immunotherapy pembrolizumab (Keytruda) has failed a pivotal study testing it in an aggressive form of bladder cancer.
The Merck (NYSE: MRK) drug was being evaluated in urothelial carcinoma, a form of cancer that starts in the cells... Read more »
Melinta Therapeutics and Tetraphase Pharmaceuticals, two antibiotics companies that have struggled separately, will now see if they have better luck together.
Morristown, NJ-based Melinta has reached a deal to acquire Tetraphase (NASDAQ: TTPH) for $39 million in cash up front.... Read more »
When fluid builds up in the brain faster than the body can absorb it, pressure builds sparking what’s called hydrocephalus. Surgery can address this condition, but the decades-old approach to relieving the cranial pressure caused by the fluid is susceptible to... Read more »