Pharmaceutical industry
Mylan Inc. has confirmed that it and its subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Sorafenib Tablets,
United States. Food and Drug Administration
Pharmaceutical company Ranbaxy has lost its 180-day exclusivity to sell a generic version of AstraZeneca's heartburn drug Nexium in the US market, according to a filing on the Bombay Stock Exchange (BSE). The US Food and Drug Administration (FDA) has determined that Ranbaxy has forfeited its exclusivity for
United States. Food and Drug Administration
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company, has announced the FDA approval of the first generic equivalent to Nexium (esomeprazole magnesium) Delayed-Release Capsules in the United States. This approval marks a significant milestone for Teva, as Nexium Delayed-Release Capsules, marketed by AstraZeneca, had annual sales of approximately $6
Pharmaceutical industry
The Food and Drug Administration has approved the meningitis vaccine Bexsero for emergency distribution at Princeton University and the University of California, Santa Barbara, after an outbreak infected nine people and resulted in one death. The vaccine targets a strain of meningococcal bacteria known as serogroup B and is aimed
Pharmaceutical industry
Momenta Pharmaceuticals announced that the US Supreme Court has vacated a 2013 decision by the Court of Appeals for the Federal Circuit, which had found several patents for Copaxone (20 mg injection) invalid due to being indefinite. The Supreme Court has sent the case back to the Court of Appeals
Pharmaceutical industry
A Food and Drug Administration advisory panel has recommended approval of a generic version of Neupogen, a biotech drug used to boost white blood cells in cancer patients. The panel voted 14 to 0 in favor of the recommendation, which could lead to the first U.S.-approved "biosimilar&
Pharmaceutical industry
As millions of Americans seek to lose weight in the new year, the U.S. Food and Drug Administration has approved a new prescription weight loss drug, liraglutide, which is part of a new class of diabetes medicines that prompt the pancreas to make extra insulin after meals. The daily
Pharmaceutical industry
Liraglutide, a daily injectable drug, has been approved by the FDA for weight loss in obese patients and those with weight-related health issues. The new prescription, Saxenda, is specifically designed for this purpose, and its approval marks a significant development in the treatment of obesity, a major public health issue.
Pharmaceutical industry
Exelixis' collaborator Genentech has completed the filing of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF
Pharmaceutical industry
The U.S. Food and Drug Administration (FDA) has extended the approval of Tamiflu, a prescription oral antiviral medicine, to include infants two weeks of age and older, making it the only approved medicine for people of all ages. This approval provides parents with a treatment option for their young
Pharmaceutical industry
The US Food and Drug Administration has approved a new treatment for multidrug-resistant tuberculosis, a growing public health threat worldwide. Sirturo, also known as bedaquiline, is the first drug in a new class that targets the disease in a different way than current treatments. This approval is a significant milestone
Pharmaceutical industry
Johnson & Johnson's Janssen Research & Development, LLC (JRD) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of XARELTO (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS). The sNDA is supported by
