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The FDA has submitted its user fee reauthorization letters covering prescription drugs, generics and biosimilars to lawmakers — enabling Congress to begin crafting legislation authorizing the programs for fiscal years 2023 to 2027. Read More
In June 2021, the FDA approved Pfizer’s Prevnar 20 jab for preventing invasive disease and pneumonia from 20 different strains of streptococcus. Read More
Could Biogen sidestep the Centers for Medicare and Medicaid Services (CMS) coverage decision that threatens to topple its longed-for Alzheimer’s treatment franchise? Read More
AstraZeneca has signed a collaboration deal with Scorpion Therapeutics to discover, develop and commercialize precision medicines against previously hard-to-target cancer proteins, the so-called “undruggable” targets. Read More
Sanofi has agreed to buy exclusive global rights to develop Korean company ABL Bio’s preclinical antibody for the treatment of neurodegenerative conditions, including Parkinson’s disease. Purchase price: $75 million upfront, with additional payments that could total $1 billion. Read More
The FDA has issued a warning about the potential for serious dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder (OUD) and pain. Read More
In a 13-to-8 vote yesterday, the Senate Health and Education, Labor and Pensions (HELP) Committee signed off on Robert Califf as the next FDA commissioner, paving the way for a full chamber vote on his nomination. Read More
In October, the European Medicines Agency recommended that the condition be added as an adverse reaction with an unknown frequency to the J&J vaccine product information. Read More