The nation's poultry industry may have to live with a deadly bird flu strain for several years,...
Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were...
A California vaccination bill that has generated intense debates and pitted personal rights...
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.
The Food and Drug Administration is warning consumers to avoid dietary supplements sold by a Las Vegas company because they may contain anabolic steroids that can cause liver damage.
A lawyer for Actavis urged a U.S. appeals court on Monday to let it replace a two-pill daily regimen with a single-dose version of the drug even if it cheats generic drugmakers of profits.
The high cost of a drug used to treat Medicaid patients with hepatitis C drew scrutiny from lawmakers earlier this year, but other drugs are also driving up the state's costs and likely will continue to do so for several years, government data reveals.
IDT Australia Limited announced that the U.S. Food and Drug Administration (FDA) has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products to IDT.
North Dakota's Legislature has passed a measure that gives patients the chance to try experimental drugs that haven't gotten final approval for general use from the U.S. Food and Drug Administration.
Underlining a change across the nation, nearly 9 out of 10 adults now say they have health insurance, according to an extensive survey released Monday.
The issue also intensified criticisms of the FDA.
Government health advisers have serious reservations about a proposal by Swedish Match to market its smokeless tobacco pouches as less harmful than cigarettes and other tobacco products.
One of the nation's largest suppliers of HIV and AIDS medical care is accused of bilking Medicare and Medicaid in an elaborate $20 million dollar scam that spanned 12 states, according to a lawsuit filed in South Florida federal court.
The number of people who have enrolled for their 2015 employee benefits doubled in the last year from 3 million to 6 million people.
Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.
U.S. health regulators have questions about tobacco maker Swedish Match's bid to become the first to market a smokeless tobacco product as less harmful than cigarettes.
Arizonans with medical marijuana cards cannot be barred from using the drug while on probation, the state Supreme Court concluded Tuesday in a ruling that will have ripple effects across the state.
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.
Cost remains an issue as the only FDA-approved PrEP is Truvada, a combination of two anti-retroviral medications used to treat HIV: tenofovir and emtricitabine. Truvada costs $14,400/year, and lab costs for routine monitoring are $180/year, so total cost is around $40/day.
Park City Group will expand into the pharma and dietary supplement channels using its food, drug & dietary supplement compliance management and traceability solution.
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.
An Irish healthcare company has launched a crowdfunding campaign on Indiegogo to raise funds to research and develop affordable medical cannabis.
Maryland misallocated $28.4 million in federal money for its flawed health care exchange and should pay the money back, according to a federal audit set to be released Friday.
GNC Holdings Inc. said Monday that it has reached a deal with New York Attorney General Eric Schneiderman over its Herbal Plus products.
Accelrys, a provider of scientific innovation lifecycle management solutions, has acquired Ireland-based QUMAS, a global provider of Cloud-based and on-premises enterprise compliance software supporting regulatory and quality operations in life sciences and other highly regulated industries.
In the November/December issue of Pharmaceutical Processing we profile Metrics’ clinical trial materials manufacturing facility located in Greenville, North Carolina. This issue also includes our annual CMO/CSO reader survey and our directory of service providers. Two articles on pure water discuss compendial water system maintenance and monitoring considerations, and automated and continuous TOC monitoring of ultra-pure water cycles.
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.
AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.
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