The FDA today approved Raplixa, the first spray-dried fibrin sealant approved by the agency. It...
Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine...
The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole).
Catalent announced that it has received a significant project grant as part of a consortium looking to evaluate, develop and manufacture thermo stable and cold-chain independent nano-pharmaceutical virosome-based vaccine candidates.
The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).
OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.
California lawmakers are preparing for another round of heated talks Wednesday on whether the state should prevent parents from seeking vaccination exemptions for their children because of religious or personal beliefs.
President Barack Obama is citing major gains in fighting the Ebola outbreak in West Africa and says the goal now is to prevent any new cases.
Too-thin models, too much drinking, sexy cigarette packs: France's parliament is cracking down on all of these in a sweeping bill designed to improve public health and trim public health costs.
The Senate gave final approval late Tuesday to the $214 billion bipartisan measure, which permanently recasts how Medicare reimburses doctors for treating over 50 million elderly people.
A 2011 law overhauling the German pharmaceutical industry will be the biggest impediment to growth in the sector over the next several years, according to a new report.
On March 30, the Pharma & Biopharma Outsourcing Association (PBOA) held its first Regulatory/Legislative Workshop.
The crackdown comes as similar moves to limit vaccination waivers in the United States have proved to be deeply divisive.
The issue also intensified criticisms of the FDA.
The FDA has notified Tekmira that the partial clinical hold on TKM-Ebola has been modified. Tekmira plans to resume the TKM-Ebola Phase I clinical trial in the coming weeks.
Baxter International Inc. announced today it is voluntarily recalling select lots of IV solutions to the hospital/user level due to the potential presence of particulate matter.
The European Commission (EU) approved Avastin in combination with standard chemotherapy for the treatment of adult patients with carcinoma of the cervix.
The FDA has granted Fast Track designation to BioBlast's Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).
He says the biggest challenge is getting more states to expand Medicaid coverage.
Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.
Drug and medical device maker Hospira said that it received a warning letter from the FDA following an Italian factory inspection. The agency said it found problems with procedures that are supposed to prevent sterile products from being contaminated, and found fault with Hospira's inspections procedures. It also said the company should have better security protecting data generated during its manufacturing process.
Officials say an American healthcare worker who contracted Ebola while volunteering in Sierra Leone has improved to good condition at a federal hospital. He is being treated at the NIH hospital in Bethesda, Maryland.
Eagle Pharmaceuticals, Inc. today announced a patent for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake.
Simulations Plus announced that several regulatory agencies around the world have added licenses of software for pharmaceutical discovery and development within the past three months.
Pfizer has stopped selling its Prevnar 7 pneumonia vaccine in China after its import license expired, but the U.S. drugmaker still intends to launch the world's most widely used vaccine, Prevnar 13, in that market.
An Irish healthcare company has launched a crowdfunding campaign on Indiegogo to raise funds to research and develop affordable medical cannabis.
HHS awarded approximately $12 million today to BioCryst Pharmaceuticals of Durham, North Carolina, for the advanced development of a promising experimental drug for Ebola, including preparing for large-scale manufacturing of the drug and conducting related studies.
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