US FDA Approval

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Announce U.S. FDA Grants Breakthrough Therapy Designation for LENVIMA

In Combination with KEYTRUDA as Therapy for Previously Treated Patients with Advanced and/or Metastatic non-MSI-H/pMMR Endometrial Carcinoma Tokyo, August 05,…

6 years ago

Aurobindo gets USFDA nod for antibiotic

Mumbai, August 04, 2018: Aurobindo Pharma said on 5 June it has received approval from the US Food and Drug…

6 years ago

WuXi STA’s Jinshan Site Passes Fourth U.S. FDA Inspection

Shanghai, July 29, 2018: STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its Active Pharmaceutical Ingredient (API)…

6 years ago

Cipla gets USFDA nod for generic HIV drug

New Delhi, June 20, 2018: Drug major Cipla on Tuesday said it has received approval from the US health regulator to market Efavirenz…

6 years ago

WuXi STA Changzhou Site Passes First U.S. FDA Inspection

The integrated R&D and manufacturing facility is expecting more products to go into commercial production post approval Shanghai, May 11,…

7 years ago

Panacea Biotec Ltd receives EIR from USFDA for Oncology plant at Malpur, Baddi

Mumbai, March 15, 2018: Pharma Major, Panacea Biotec Ltd. has announced the receipt of Establishment Inspection Report (EIR) from the…

7 years ago

Tuberculosis -The Scourge Of India By Dr. Shalu Verma Kumar, CORE Diagnostics

New Delhi, March 14, 2018: Tuberculosis (TB) is an infectious disease variously named consumption, white plague, phthisis, or scrofula. It has…

7 years ago

Sun Pharma poised to clear US FDA’s warning on Halol: Analysts

New Delhi, March 08, 2018: Sun Pharma, India’s largest drug maker, is well poised to resolve the US FDA’s warning…

7 years ago

Aurobindo Pharma clarifies on Form 483 issued by USFDA for Unit 4 at Pashamylaram, Hyderabad

Mumbai, March 07, 2018: Pharma Major, Aurobindo Pharma clarifies on News Items on Company unit 4 getting 9 observation after USFDA…

7 years ago

USFDA completes audit at Laurus Labs Ltd’s formulations unit

Mumbai, March 04, 2018: Laurus Labs Ltd said that the USFDA audit has been successfully completed without observations – ZERO…

7 years ago