Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. The Food and Drug Administration cleared the twice-a-day pill....
France's senate has voted against a bill allowing the sedation of terminally ill patients,...
Mayo Clinic and the Translational Genomics Research Institute (TGen) are helping launch a...
Gov. Charlie Baker on Friday issued a one-time, temporary waiver aimed at helping the state's...
A decade-spanning search for a female equivalent to Viagra took a step forward, as government experts recommended approval for a pill to boost sexual desire in women. However, the endorsement came with safety reservations due to drug side effects.
During the hullabaloo surrounding passage of President Obama’s signature piece of legislation, the Patient Protection and Affordable Care Act (aka, Obamacare), proponents extolled the virtues of Canada’s free healthcare system. Critics slammed that same system for its alleged wait times....
At a meeting today with analysts, Johnson & Johnson's Janssen Pharmaceuticals announced plans for regulatory approval of more than 10 new drugs between 2015 and 2019, each with the potential to generate at least $1B in sales, in addition to ...
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.
There’s a new treatment option for schizophrenia – INVEGA TRINZA (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.
Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. Patent No. 9,034,908, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes.
Treatment results with the breast cancer drug Herceptin, as well as chemotherapy, did improve, but the drug's backers had been hoping to see better results.
ANI Pharmaceuticals has acquired the approved new drug application ("NDA") for a testosterone gel 1% product previously licensed to Teva Pharmaceuticals.
Federal health advisers recommended approval for an experimental combination drug to treat cystic fibrosis, despite unresolved questions about the benefit of one of the pill's two ingredients.
The FDA has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator for the prevention of oral mucositis.
The Food and Drug Administration said in an online review that the benefit was small and it is unclear if the addition of a second drug ingredient adds to the pill's effectiveness.
Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets.
Portola Pharmaceuticals today provided a corporate update and reported its financial results for the first quarter.
The FDA today approved Raplixa, the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.
Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine in treating coughs and upper respiratory allergies.
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).
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.
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).
Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.
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.
Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.
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