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FDA Approves First Interchangeable Biosimilar of Alexion’s Soliris® (eculizumab) - Amgen’s Bkemv™...
JD Supra· 20 hours agoOn May 28, 2024, the FDA approved Amgen’s Bkemv™ (eculizumab-aeeb), the first interchangeable biosimilar of Alexion’s Soliris® (eculizumab). Bkemv™...
FDA’s review of MDMA for PTSD highlights study bias and safety concerns
Ars Technica· 3 days agoFurther ReadingMDMA—aka ecstasy—submitted to FDA as part of PTSD therapyOn Tuesday, June 4, the FDA...
FDA sets review date for Iterum's urinary infection drug By Investing.com
Investing.com· 3 days agoThe FDA's acceptance of the New Drug Application (NDA) resubmission marks a significant step for...
There's a Nationwide Salmonella Outbreak Linked to Cucumbers—Here's What to Know
Eating Well via Yahoo News· 6 hours agoS., RDReviewed by Dietitian Emily Lachtrupp, M.S., RD There’s an active recall on cucumbers...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 7 days agoThis action follows FDA's Proposed Rule issued on October 3, 2023 (88 FR 68006, Oct. 3, 2023). Unfortunately, the calendar prevented publication in the ...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 4 days agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...
MDMA Therapy For PTSD Closer To Legality As Key FDA Approval Meeting Approaches, Sparking Hope And...
Benzinga· 11 hours agoOn Tuesday, the FDA's Psychopharmacologic Drugs Advisory Committee will meet to discuss the drug application submitted by Lykos, providing the first clear ...
Moderna's RSV Vaccine Approved by FDA
Medscape· 22 hours agoFor the first time, an mRNA vaccine has been approved for an indication other than COVID-19. The vaccine will join a couple other immunizations currently on the market for respiratory syncytial virus.
US FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label
AOL· 4 days agoModerna's vaccine was approved by the FDA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older. RSV, which produces ...
FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men
Medical Xpress· 6 days agoSuch groups have been asking the FDA for years to reduce the deferral period from five years to 90...
