Aldeyra Therapeutics Stock Craters to All-Time Low on FDA Letter
Key Takeaways Shares of Aldeyra Therapeutics slumped nearly 75% to a record low on Thursday.The FDA told the drugmaker in a ...
Top vaccine official resigns from FDA, criticizes RFK Jr. for promoting ‘misinformation ...
The top vaccine official with the Food and Drug Administration has resigned and criticized the nation's top health official ...
Aldeyra Shares Fall on FDA Complete Response Letter for Dry Eye Disease Drug
Aldeyra Therapeutics shares fell 73% to $1.42 in the regular session after it reported a Food and Drug Administration complete response letter for reproxalap for treatment of dry eye disease. The ...
MedTech Dive11 天
Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
Yahoo Finance9 天
FDA Issues Complete Response Letter for Etripamil for PSVT
(Nasdaq: MIST) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray ...
Drugmakers face market turmoil following FDA shakeup and Trump health overhaul
The pharma and biotech sector has been under pressure since Donald Trump returned to the White House earlier this year.
The American Journal of Managed Care3 天
Reproxalap Receives Complete Response Letter From FDA for Use in Dry Eye Disease
The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish ...
Fierce Pharma3 天
Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot
Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...
MedTech Dive6 天
Peter Marks, FDA’s top vaccine official, resigns
In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed ...