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Zydus Cadila gets US FDA nod for anti-depression drug expressbpd
October 16, 2017
Zydus Cadila has received final approval from the US health regulator to market desvenlafaxine extended release tablets, used to treat depression.
Biocon receives CRL from US FDA over cancer treatment biosimilar expressbpd
October 12, 2017
Biotechnology firm Biocon said the US health regulator has issued complete response letter (CRL) for Mylan’s application for proposed biosimilar Pegfilgrastim, indicated for use in treatment of cancer.
US FDA approves Flexion’s Zilretta to treat osteoarthritis knee pain pharmaceufical-technology
October 11, 2017
The US Food and Drug Administration (FDA) has granted approval for specialist pharmaceutical firm Flexion Therapeutics’s Zilretta for the treatment of osteoarthritis (OA) knee pain.
US FDA agrees to review Eisai’s application for Lenvima to treat HCC pharmaceufical-technology
September 29, 2017
Commonly referred to as liver cancer, HCC is currently the second leading cause of cancer-related death.
US FDA approves Bayer’s drug for follicular lymphoma expressbpd
September 18, 2017
The US Food and Drug Administration (US FDA) has approved Bayer’s treatment for follicular lymphoma, a cancer of the lymph system.
US FDA warns of problems with EpiPen manufacturing plant expressbpd
September 11, 2017
Tens of thousands of EpiPens, sold by Mylan NV, were recalled worldwide in March following two reports of the life-saving allergy shot failing to work in emergencies
US FDA recognises UL 2900 for cybersecurity scrutiny of medical devices expressbpd
September 07, 2017
UL 2900 offers testable cybersecurity criteria for network-connectable products and systems
Sunovion submits NDA for dasotraline to US FDA to treat ADHD patients pharmaceufical-technology
September 05, 2017
Sunovion Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline to treat patients with attention deficit hyperactivity disorder (ADHD).
US FDA hikes fee for processing ANDA by $1 lakh for FY18 expressbpd
September 01, 2017
The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II)
New study offers detailed insights on biosimilars, follow-on biologics market pharmaasia
August 25, 2017
Biosimilar market is expected to gain prominence due to leading biologic drugs expected to lose exclusivity over the next seven years.

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