Pharma News

Newly released federal guidance details how the government will punish drug companies who hike prices faster than the rate of inflation for some prescription Medicare medicines. ...

The FDA has granted regular approval — one month ahead of the FDA goal date — to GSK’s Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient recurrent...

By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in reduced bone loss.

The FDA has updated its guidance on the compounding of ibuprofen oral suspension products to include state-licensed pharmacies and federal facilities.

The FDA has approved Regeneron’s Eylea (aflibercept) as the first injection to treat preterm infants with retinopathy of prematurity (ROP).

The FDA has approved Takeda’s supplemental biologics license application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) to prevent attacks of hereditary angioedema (HAE) in pediatric pat...

The FDA has granted regenerative medicine advanced therapy (RMAT) designation for Mesoblast’s rexlemestrocel-L in the treatment of chronic low back pain associated with disc degeneration, in com...

The European Medicines Agency’s (EMA) policy on interchangeability of biosimilars relates only to the active substance and formulated product, the agency said in a clarifying statement. ...

A federal court has rejected a lawsuit from the Pharmaceutical Research and Manufacturers of America (PhRMA) filed against HHS that would seek to block states from importing prescription drugs from...

Janssen reported positive topline results from a phase 2 trial of nipocalimab for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN), which o...

The FDA has granted regenerative medicine advanced therapy (RMAT) designation to Rocket Pharmaceutical’s investigational adeno-associated virus (AAV)-based gene therapy for the treatment of Danon di...

The FDA has granted priority review to a new drug application (NDA) by Sage Therapeutics and Biogen for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (P...