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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
The head of CDER’s Office of Compliance is removing herself from all substantive policy decisions after her husband became part-owner in a law firm with pharmaceutical clients. Read More
FDA Approves Label Changes for Merck’s Noxafil Antifungal
PharMEDium Recalls 32 Lots of Norepinephrine Bitartrate Over Discoloration
Dr. Reddy’s Lands Tentative Approval for Generic Toviaz
Pluristem’s PLX-PAD Cells Win Orphan Drug Designation
BIO Changes Name to Biotechnology Innovation Organization
EU Delays Clinical Trials Portal Launch
Baxalta, Symphogen Partner to Develop Immuno-Oncology Therapies Read More
Roche has settled its legal feud over Tarceva with Glenmark Pharmaceuticals, with both sides agreeing to drop lawsuits over patent rights in India. Read More
Last year was a productive one for the FDA’s CDER, which approved 45 novel drugs — an increase from its 2006 to 2014 average of 28, according to the agency’s 2015 Novel New Drugs Summary released Monday. Read More