Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and ...
Tags: Actavis, Warner Chilcott Company LLC, Abbreviated New Drug Application
Today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal ...
Xiaflex (collagenase clostridium histolyticum) has been approved by the U.S. Food and Drug Administration to treat Peyronie's disease, an uncomfortable curvature of the penis. The drug -- first sanctioned three years ago to treat a hand ...
Tags: Xiaflex, collagenase clostridium histolyticum, Peyronie's disease
Rheumatoid arthritis patients can generally look forward to a much better quality of life today than they did 20 years ago, new research suggests. The observation is based on a comparative multi-year tracking of more than 1,100 rheumatoid ...
The U.S. Food and Drug Administration on Monday began the process of regulating compounding pharmacies, which create new drug combinations or alter drugs to suit individual patient needs. Under the Drug Quality and Security Act, signed ...
Tags: FDA, regulating compounding pharmacies, outsourcing pharmacies, pharmacy
Anoro Ellipta (umeclidinium and vilanterol inhalation powder) has been approved by the U.S. Food and Drug Administration for once-daily treatment of chronic obstructive pulmonary disease (COPD). COPD, an umbrella term that includes the ...
Tags: Anoro Ellipta
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. ...
Tags: Generic Drug, Medicine
Navidea Biopharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the approval to market and sale Lymphoseek Injection for sentinel lymph node (SLN) detection in patients ...
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. ...
Tags: Mylan, Targretin Suit, Treatment of Cutaneous Manifestations
Stelis Biopharma and Pieris, a next generation therapeutic protein R&D firm, have started a long-term collaboration for clinical development and commercialization of multiple novel Anticalin-based protein therapeutics worldwide, primarily ...
Rainbow Coral and its joint venture partner, Therakine, have reached a major new milestone in the development of a revolutionary new drug delivery technology. The companies reached terms to initiate Phase II of research and analysis on a ...
Tags: RBCC, Drug Delivery Development
Sanofi has released results of a 24-week Phase IIIb clinical trial showing that Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered to patients either before breakfast or the ...
Tags: Diabetes Drug, Medicine
Teva Pharmaceutical has licensed rights to commercialize glatiramer acetate to Takeda Pharmaceutical in Japan as part of their agreement signed earlier in 2013. Currently both the firms are working on additional agreements for ...
Tags: Teva Licenses, Medicine
QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
US-based research and development biotechnology firm Boston Strategics has entered into a new drug development partnership with Fujifilm Pharmaceuticals USA (FPHU), a global pharmaceutical development center of Japan's Fujifilm Corporation. ...
Tags: Oncology Drugs, Fujifilm Pharma