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The FDA has put the squeeze on Sanofi’s first steps toward an over-the-counter (OTC) version of Cialis (tadalafil), Eli Lilly’s once-blockbuster erectile dysfunction drug. Read More
In an effort to prepare for future health emergencies, the World Health Organization (WHO) has adopted a resolution geared toward delivering higher quality data and improving the conduct and coordination of clinical trials around the world. Read More
Johnson & Johnson (J&J) has filed a complaint against Aurobindo Pharma charging the Indian generics maker with infringing on patents for J&J’s blockbuster prostate cancer therapy Erleada (apalutamide). Read More
GSK announced yesterday that it is acquiring Cambridge, Mass.-based biopharma company Affinivax in a $3.3 billion deal, picking up at least two novel pneumococcal vaccine candidates and a promising vaccine technology platform. Read More
The approval follows the recommendation of Polivy for this indication from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Read More
The Senate’s bill to reauthorize FDA user fee programs for drugs, biologics and medical devices, introduced last week by Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (N.C.), includes proposed reforms of the FDA’s accelerated approval program, a subject the House declined to address in its version of the user fee program reauthorization. Read More
A bipartisan pair of senators — Maggie Hassan (D-N.H.) and Bill Cassidy (R-La.) — are pressing federal agencies to close oversight gaps that delay generic drugs and in turn keep drug prices high. Read More
Zealand Pharma will bring a new form of its antihypoglycemia drug Zealogue (dasiglucagon) to the FDA as a potential treatment for children with congenital hyperinsulinism (CHI). Read More
The Department of Health and Human Services (HHS) has withdrawn a controversial and unpopular Trump-era final rule that would have required federal health agencies to reassess their regulations every 10 years or face eliminating those rules. Read More