The Dangers Hidden In CMS’ Drug Pricing Regulation
The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to ...
verywellhealth16h
Injectable Alzheimer's Drugs Could Save Patients Trips to the Hospital
Eisai is seeking approval for an injectable version of Leqembi while Eli Lilly is developing a new injectable drug. These ...
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used ...
BioPharma Dive19h
AstraZeneca, Daiichi’s Enhertu successor gets first FDA OK in breast cancer
The clearance of Datroway comes months after the companies narrowed approval plans in lung cancer and opens up a market ...
Life Molecular Imaging Secures FDA Fast Track Designation for [18F]Florbetaben in Diagnosing Cardiac AL and ATTR Amyloidosis
Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, announces that the U.S. Food and ...
The National Law Review20h
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
pulmonologyadvisor22h
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
precisionmedicineonline22h
Atara Biotherapeutics Receives FDA Complete Response Letter for Ebvallo
The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.
Dyne Gets FDA Fast-Track Status for Neuromuscular Product Candidate
Dyne Therapeutics received fast-track designation from the Food and Drug Administration for a treatment of myotonic dystrophy type 1, a neuromuscular disease.