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- Read more about Sandoz's BLA For Biosimilar Etanercept Accepted by USFDA
Sandoz, a Novartis company and the global leader in biosimilars, announced that 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 tumour necrosis factor alpha (TNF-alpha) inhibitor. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.
- Read more about FDA permits marketing of new laser-based hearing aid with potential for broad sound amplification
The U.S. Food and Drug Administration allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.
- Read more about FDA approves two new drug treatments for diabetes mellitus
The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.
- Read more about Perrigo receive US FDA approval for generic BenzaClin topical gel
Perrigo Company plc, received US Food and Drug Administration (FDA) approval for the generic version of Valeant Pharmaceutical International Inc's BenzaClin topical gel.

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- Read more about U.S. Food and Drug Administration noded to BMS's sBLA for untreated advanced melanoma
U.S. Food and Drug Administration (FDA) has accepted BMS's filing and review a supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen to include clinical data from CheckMate -067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of January 23, 2016.
- Read more about Novo Nordisk received FDA approval for Insulin products
US Food and Drug Administration (FDA) has approved Novonordisk's Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).
- Read more about U.S. FDA Advisory Committee provides advice for continued safe and appropriate use of Essure® permanent birth control
A panel of experts from the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee discussed considerations to help ensure the continued safe and appropriate use of Essure® permanent birth control. While there was agreement among the Panel members that Essure is an important contraceptive option, the Panel provided input and guidance for the FDA and Bayer to consider. Based on information presented during this meeting, the Advisory Panel discussed a number of considerations including clinical research, patient education and counseling. The Panel also discussed training and certification of physicians; and post-procedural patient management including removal of the device.
- Read more about US FDA approve zolmitriptan ODT tablets of Jubilant Life
Jubilant Life Sciences Ltd, an integrated global pharmaceuticals company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (FDA) for zolmitriptan orally disintegrating tablets, 2.5 mg and 5 mg the generic version of Zomig-ZMT (AstraZeneca), which is used for acute treatment of migraine headaches in adults.
- Read more about Granules India receive US FDA approval for ibuprofen tablets
Granules India, a Rs. 1,200 crore pharmaceutical major from Hyderabad, has received US FDA approval for ibuprofen tablets USP, 400 mg, 600 mg and 800 mg.
- Read more about Glenmark Pharma receives US FDA approval for voriconazole tablets
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from the United States Food & Drug Administration (FDA) for voriconazole tablets, 50 mg and 200 mg of PF Prism C.V. (Prism).