Merck applies for approval of its new insomnia drug suvorexant
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Comments (0)FDA grants Mylan tentative approval for Atorvastatin Calcium ANDA
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg.
Cystic fibrosis drug gets FDA approval
A drug – the first of its kind - that treats the root cause of cystic fibrosis won approval Tuesday. This could be a ray of hope for patients with the deadly illness and broader hope for thousands more patients with the inherited disease.
Novartis’ Gleevec receives FDA approval for use in patients with CD117-positive GIST
The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors.
Boehringer Ingelheim, Lilly receive FDA approval for Jentadueto to treat type 2 diabetes
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.
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Amylin’s Once-Weekly Diabetes Injection Finally Wins FDA Approval
On Friday, the US Food and Drug Administration finally approved Amylin Pharmaceutical's diabetes drug Bydureon, which provides glycemic control for diabetes type 2 in a once-weekly injection. The approval follows two earlier rejections in 2010, when the FDA asked the company to go back and carry ...
Cohera receives FDA IDE approval to initiate U.S. clinical study for TissuGlu
Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for its lead product, TissuGlu Surgical Adhesive in ...
InSightec seeks FDA premarket approval for ExAblate treatment of pain palliation of bone metastases
InSightec Ltd, the leader in MR guided Focused Ultrasound therapy, announced that it has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its ExAblate treatment of pain palliation of bone metastases.
Takeda receives FDA approval for VELCADE sNDA to treat MM
Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE(bortezomib), which updates the label to include the subcutaneous method of administration in all approved indications: multiple myeloma ...
Guided Therapeutics seeks CE Mark approval for LuViva Advanced Cervical Scan
Guided Therapeutics, Inc. today announced that it has submitted the application for CE Mark approval for LuViva Advanced Cervical Scan. The CE Mark is required to market LuViva in the 27 nations that comprise the European Union (EU).
FzioMed’s DYNAVISC adhesion barrier gel receives European CE Mark approval
FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC adhesion barrier gel in Europe for tendon and peripheral nerve surgery.
Crux receives CE mark approval for inferior vena cava filter with BDR
Crux Biomedical announced it has received CE mark approval for their revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR). Vena cava filters are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). Each year in the United States, approximately 600,000 ...