Pelthos Therapeutics has just added a seasoned finance pro to its board. Andrew J. Einhorn, a veteran with over 40 years in the field, is now on the team. He's stepping into big roles too - Audit Committee and Compensation Committee. With his background in investment banking and leading finance team
The FDA, once a beacon of scientific independence, is now caught in a political tug-of-war. The agency's new "Commissioner’s National Priority Voucher" program is a prime example of this shift. It promises faster reviews for companies that align with the administration's "national priorities. " But
In a surprising turn of events, the newly appointed head of the U. S. drug regulatory agency has expressed serious doubts about the recent push to fast-track drug approvals. This official, who just started their role this month, believes that these changes might not only be against the law but could
The FDA is in chaos. But it's not just about the recent leadership shake-up. A new voucher program is causing concern. It seems to be turning drug approvals into a political bargaining chip. The program aims to speed up drug reviews. But the criteria are vague. It's up to the FDA Commissioner to de
A new drug called Amvuttra is making waves in the UK. It's designed to help people with a rare heart condition called ATTR-CM. This condition happens when faulty proteins build up in the heart, which can make it hard for the heart to work properly. The drug is already approved for this use, as well
Dr. George Tidmarsh, the head of the FDA's drug evaluation center, is currently on leave and might quit. Why? He says the workplace is "toxic" and unfair. The FDA says they put him on leave because of concerns about his behavior. Some reports say Tidmarsh used his power to hurt a business partner.
The Food and Drug Administration's drug division is in chaos. Dr. George Tidmarsh, who leads this division, is on leave. He says it's because he spoke up about a new program. This program fast-tracks some drug approvals. He thinks it's not based on solid science. Instead, he believes politics are pl
Over the past decade, China has been fine-tuning how it approves new traditional Chinese medicines (TCMs). The goal? To make the process better suit the unique nature of these treatments. This effort has led to some interesting changes in what counts as solid evidence for approval. Before the refor
Japan is determined to speed up the availability of new cancer treatments. These treatments offer better outcomes than existing options. To make this happen, countries use special pathways to quicken the approval process. This is known as expedited approval. A study compared the speed of drug ap
Drugs that show potential in treating serious illnesses get the green light from Health Canada. However, there is a catch. Companies must promise to run more tests. These tests confirm if the drugs are as effective as initially thought. This process is not always speedy. It can take a while for thes
