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- Read more about Promius Pharma™ receives FDA approval for Sernivo (betamethasone dipropionate) Spray, 0.05%
Dr. Reddy’s announced that its US subsidiary, Promius PharmaTM, has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA).
- Read more about US FDA accepts for review Otsuka and Lundbeck's sNDA filing for labeling update of Rexulti® (brexpiprazole)
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental.
- Read more about Vertex receives complete response letter from U.S. FDA for Use of KALYDECO® (ivacaftor)
Vertex Pharmaceuticals announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the use of KALYDECO® (ivacaftor) in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward.
- Read more about Vizient, Inc. endorses the FDA’s Biosimilars approval pathway
Vizient, Inc. has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech).
- Read more about Dr.Reddy's Sernivo spray gets USFDA nod
Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.

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- Read more about PhRMA hits on Indian Intellectual regime
India will be continued in priority watch list in the year 2016 as per Special 301 report submitted by PhRMA (Pharmaceutical Research and Manufacturers of America) to USTR (United States Trade Representative). PhRMA clearly reproval Indian IPR (Intellectual Property Rights) regime.
- Read more about U.S. FDA approves expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir)
Bristol-Myers Squibb’s announced that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.
- Read more about Amarantus requests rare pediatric disease designation from US FDA for MANF
Amarantus Bioscience Holdings Inc. a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF(mesencephalic-astrocyte-derived neurotrophic factor). MANF was previously granted orphan drug designation (ODD) by the US FDA in December 2014.

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- Read more about Impax Receives Tentative FDA approval for generic version of Vytorin® (ezetimibe and simvastatin) tablets
Impax Laboratories, Inc. announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its
- Read more about U.S. FDA grants breakthrough therapy designation to Immunomedics for Sacituzumab Govitecan
Immunomedics, Inc. announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for metastatic disease.