Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...
Tennessean1d
Who will control the House? Dozens of races not decided | The Excerpt
USA TODAY Trending News Reporter Kinsey Crowley discusses how voters approached a number ... For example, passing a law to ...
MedPage Today5d
Overcoming the Challenges of Applying CAR T-Cell Therapy to Solid Tumors
FDA approval of tarlatamab (Imdelltra) for small-cell lung cancer offers another example of progress ... Even in the current ...
MLive7d
No, Trump’s drug program for terminal patients didn't save ‘thousands’ of lives
Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims ...
STAT8d
A Q&A with the FDA’s top vaccine regulator amid a fresh wave of disinformation
A fresh wave of disinformation about vaccines is flaring amid the 2024 campaign. The FDA's top vaccine official believes ...
News Medical8d
Key FDA Decisions Made in 2024
Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...
California Healthline8d
No Evidence Trump’s Drug Program for Terminal Patients Saved ‘Thousands’ of Lives
Supporters say Right To Try is an example of successful deregulation and claim that ... dosage to address safety and ...
The American Journal of Managed Care11d
5 Essential Drugs Currently Facing Shortages
US drug shortages have decreased from 323 to 277 as of September 2024, yet many essential drugs remain scarce, with 50% of ...
Delishably on MSN12d
Doctor Uncovers How 99% of Today's Food Additives Dodge FDA Scrutiny
The ongoing discussions about the quality of the US food supply may have left you wondering how so many chemicals could have ...
BioPharma Dive12d
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...
Morningstar14d
Upcoming FDA Advisory Panel for IceCure's ProSense® Marketing Authorization Receives Large Number of Public Comments from Stakeholders
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large ...
Costco recalls salmon products over listeria contamination concern
Costco is recalling smoked salmon products over possible listeria contamination. Listeria is a bacteria that contaminates foods and can cause listeriosis, which is the third-leading cause of death ...