The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.
Pluristem Therapeutics has announced that it has completed the approval process and received...
Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment...
European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary EmbolismJuly 29, 2014 8:38 am | News | Comments
Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for...
Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.
ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.
In Vermont, a new health care experiment is under the microscope.
After more than six weeks of sometimes testy talks, House and Senate negotiators have agreed on a compromise plan to fix a veterans health program scandalized by long patient wait times and falsified records covering up delays.
Allergan announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX ® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema.
A new study estimates that more than 10 million adults gained health insurance by midyear as the coverage expansion under President Barack Obama's law took hold in much of the country.
The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. The cancers affect an estimated 200,000 patients in the U.S., according to Gilead. The company's tablet, Zydelig, works by blocking signals inside some cancer cells that allow them to grow and survive.
The Obama administration is developing a new way for religious nonprofits that object to paying for contraceptives in their health plans to opt out, without submitting a form they say violates their religious beliefs.
Undercover investigators using fake identities were able to secure taxpayer-subsidized health insurance under President Barack Obama's health care law. The weak link in the system seemed to be call centers that handled applications for thousands of consumers unable to get through online.
In rapid succession, six federal judges on two appeals courts weighed in on a key component of President Barack Obama's health care law. Their votes lined up precisely with the party of the president who appointed them. It was the latest illustration that presidents help shape their legacies by stocking the federal bench with judges whose views are more likely to align with their own.
Eagle Pharmaceuticals today announced that the FDA has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.
The medical alert came after an Ohio teen died from a caffeine overdose days before his high school graduation.
The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.
Purdue Pharma announced that the FDA has approved a new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
Two years after a deadly nationwide meningitis outbreak linked to a compounding pharmacy in Massachusetts, Gov. Deval Patrick on Thursday signed a law he said would address a "gray area" between state and federal oversight of the pharmacies.
Shares of Anacor Pharmaceuticals Inc. climbed Tuesday morning after federal regulators approved its first drug, the toenail fungus treatment Kerydin, a few weeks ahead of schedule.
Missouri Gov. Jay Nixon vetoed legislation Monday that would have limited who could work in the state as a health insurance guide and blamed a national conservative group for injecting an error into the model legislation.
A Wisconsin senator on Monday argued that his lawsuit challenging rules that call for congressional members and their employees to seek government-subsidized health insurance through small-business exchanges should be allowed to move forward.
More than half of privately insured women are getting free birth control under President Barack Obama's health law, a major coverage shift that's likely to advance.
The issue in more than four dozen lawsuits from faith-affiliated charities, colleges and hospitals that oppose some or all contraception as immoral is how far the Obama administration must go to accommodate them.
Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® and Sunvepra® Dual RegimenJuly 7, 2014 8:19 am | News | Comments
Bristol-Myers Squibb Company has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options.
Spectrum Pharmaceuticals, with a primary focus in Hematology and Oncology, announced that the FDA has granted Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
- Page 1