While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
The US growth rate for spending on medicines is expected to fall in 2016 and beyond, according to new research.
Two new major studies on a biosimilar to trastuzumab (Herceptin, Genentech) to treat HER2-positive metastatic breast cancer and HER2-positive gastric cancer demonstrated equivalency.
As the healthcare profession continues to face challenges with antibiotic resistance, drugmakers are developing novel antibiotics that will be effective against some of the worst infections. One drugmaker submitted New Drug...
A majority of oncology drugs—particularly older cancer drugs—had price hikes in 2015, according to a study. Plus, Ariad Pharmaceuticals raised the price of its chronic myeloid leukemia (CML) drug ponatinib (Iclusig) for the fourth...
FDA recently granted Breakthrough Therapy Designation for esketamine (Janssen Research & Development), an investigational medication to treat major depressive disorder with imminent risk for suicide.
PCSK9 inhibitors such as alirocumab (Praluent, Sanofi) and evolocumab (Repatha, Amgen) are priced too high to benefit the US healthcare system, according to a new study.
When Express Scripts and CVS Health announced their 2017 formularies on August 1, a common theme emerged among the healthcare giants: several blockbuster drugs will be removed from both companies’ formularies and lower-cost options...
FDA APPROVALS
FDA approves hemophilia A drug for children

FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A ...

Why 2016 drug approvals fell
New device could be breakthrough for diabetics
Advanced ovarian cancer drug approved
CLINICAL
FDA approves hemophilia A drug for children

FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A ...

New 340B drug rule sets drugmaker fines
Advanced ovarian cancer drug approved
FDA green lights first treatment for rare spinal disease