Pharmaceuticals, Biotechnology and Life Sciences
Novartis’s Alcon has received US Food and Drug Administration (FDA) approval for its AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery.
accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC)
Novartis company has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) – a tumor necrosis factor alpha (TNF-alpha) inhibitor.
Allergan plc has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvederm ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
Sanofi announced on Tuesday that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lixisenatide.
Meiji Seika Pharma Co., Ltd. announced on Tuesday that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead antibiotic product, ME1100 (arbekacin inhalation solution), as a Qualified Infectious Disease Product (QIDP) for the adjunctive treatment of mechanically ventilated patients with bacterial pneumonia.
Teva Pharmaceutical Industries Ltd. announced on Monday that its glatiramer acetate injection was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW)…
Allergan plc announced on Friday that it has launched a generic version of Janssen’s Invega (paliperidone extended-release tablets) in the…
The U.S. Food and Drug Administration has approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to…
The European Committee for Medicinal Products for Human Use (CHMP) has recommended Bayer’s aflibercept solution for injection into the eye…