Dr. Reddy's Laboratories jumped 4.84% to Rs 4020 after the company said its manufacturing plant at Srikakulam in Andhra Pradesh received the Establishment Inspection Report (EIR) from US drug regulator.

Cadila Healthcare gains 0.11% to Rs 321.95 after the company said it received final approval from US drug regulator for Deferasirox tablets for oral suspension.

Hahn immediately took a diagnostic test and was tested negative himself for the novel coronavirus, FDA spokesman Michael Felberbaum said.

As the coronavirus pandemic continued sweeping across the globe, NASA put a halt on its usual space-related activities and began developing a prototype ventilator to help combat the deadly virus. The newly developed ventilator has just received emergency approval from the

As of today, there are 2,407,439 COVID-19 cases with 165,073 deaths. On a hopeful note, 625,202 have recovered. The virus outbreak that began in 2019 continues to cause casualties, while health experts around the globe are extensively working on developing a

The inspection was conducted between January 20 and January 24, 2020.

The stock movement shows strong momentum with price above short, medium and long term moving averages.

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

The US Food and Drug Administration (USFDA) had issued a warning letter to the facility in November, 2015, after inspecting it in 2014.

Hayden Library - QP363.2.N47 2017

Patients will swab their own nose using a testing kit sent by the company and will mail it in an insulated package back to the company.

The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, it added. As per the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

The Food and Drug Administration has approved capmatinib for treatment of adults with metastatic non–small cell lung cancer harboring MET exon 14 skipping mutations, as detected by an FDA-approved test.
FDA Approvals

The company said, with this, all facilities under warning letter are now determined as Voluntary Action Indicated (VAI)

Despite the hype, support for the use of chloroquine and its relative hydroxychloroquine outside a clinical trial remains mixed

Sherlock Biosciences' test becomes the first FDA-authorized CRISPR technology on the market

Interview with Joseph S. Ross, MD, MHS, author of Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

Interview with Aaron S. Kesselheim, MD, JD, MPH, author of Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to illnesses caused by Listeria monocytogenes associated with FDA-regulated hard boiled eggs that have been recalled by Almark Foods.

The plant is one of the company's three units that were served a warning letter in November 2015 for not following the prescribed operational and manufacturing quality standards