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Eleven healthcare groups are asking a Senate committee to examine alleged industry abuse of REMS safeguards as a possible cause of rising drug prices. Read More
A journal article asking the FDA to defy its own policies concerning mass compounding and drug importation to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
Valeant Names Interim CEO Following Pearson Hospitalization
Vtesse Scores Breakthrough Therapy Designation for VTS-270
Gem Nabs Orphan Drug Designation for Soft Tissue Sarcoma Therapy
Vical Antifungal Compound Given Orphan Status
Hospira Recalls Lot of Injectable Magnesium Sulfate Solution
Gilead Scraps Simtuzumab Trials in IPF
Glenmark Awarded Tenative FDA Approval for Generic Multaq Read More
The U.S. Department of Justice has filed an injunction to halt Dallas, Texas-based Downing Labs from manufacturing and distributing drugs until the compounder brings its operations into compliance with FDA regulations. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More
Baxter Recalls 2 Lots of IV Solutions Over Particulate Matter
Gilead Snags Priority Review for Hep C Combo Drug
GBT Sickle Cell Disease Candidate Named Orphan Drug
FDA Dubs Huntington’s Disease Treatment Orphan Drug
Millendo Therapeutics Licenses Endocrine Disease Compound From AZ Read More
Tuesday brought another setback for MannKind's Afrezza, with the company announcing that Sanofi will stop selling the rapid-acting inhaled insulin effective April 4, thus terminating a licensing deal the companies reached in 2014. Read More
The Senate HELP Committee has scheduled a Jan. 12 hearing to vote on the nomination of Robert Califf as the next FDA commissioner, a committee spokesman told DID. Read More
The FDA has slapped India's Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More