Advisory Committee Endorses Sprout’s Female Sexual Dysfunction Drug June 10, 2015 Concerns about the drug’s risks when combined with alcohol remain. Read More
Cohera Medical Wins FDA Expedited Access for Sylys June 9, 2015 The product addresses an unmet need for patients suffering from gastrointestinal leaks. Read More
Lipocine’s Preterm Birth Drug Wins Orphan Designation June 9, 2015 The status gives the drugmaker incentives including seven years marketing exclusivity. Read More
First Hippocampus Laser Ablation Procedure Performed June 8, 2015 MRI Interventions’ ClearPoint neuro navigation system and Monteris’ NeuroBlate system were used. Read More
Novartis Alleges Apotex Infringed on Zometa Patent June 8, 2015 The lawsuit is one of several alleging infringement of the ’189 patent. Read More
ArcherDX Announces Tumor Panels Launch June 5, 2015 The next-generation sequencing assays detect gene translocations in clinical samples. Read More
Upsher-Smith’s Antiepileptic Secures Expanded Indication June 5, 2015 The drug is now available as a first-line monotherapy for children ages two and older who have partial-onset or tonic-clonic seizures. Read More
MITA Commends House Committee’s Repeal of Medical Device Tax June 4, 2015 The Medical Imaging & Technology Alliance says the effort will safeguard access to lifesaving medical devices and protect U.S. jobs. Read More
Lawmaker Presses for Consistent Untitled Letter Practices June 4, 2015 The congressman says companies have complained that the FDA’s policies are inconsistent and, in some cases, unfair. Read More
Hansen Medical Announces First Robotic Radioembolization Procedures June 3, 2015 The system had previously been used for interventional transarterial chemoembolization procedures. Read More
Sanofi to Spend $245 Million for Rare Pediatric Disease Voucher June 3, 2015 The drugmaker will get the voucher from San Diego-based Retrophin. Read More
OpGen Unveils Next-Generation Molecular Testing, Bioinformatics Program June 2, 2015 The products are used for gram negative multidrug resistant organism detection and management. Read More