Top

Category: FDA


FDA, News, Regulations

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

November 23, 2020

Via: BioSpace

The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week. Blueprint Medicines’ Pralsetinib for Non-Small Cell Lung Cancer Blueprint Medicines had a target […]


FDA, Regulations

FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization

November 18, 2020

Via: CNBC

The Food and Drug Administration has asked a group of advisors to set aside three days in early December for potential meetings to discuss Covid-19 vaccines — a key step in the agency’s authorization process, according to two people familiar […]


FDA, Mergers and Acquisitions, Regulations

As Urovant gears up for vibegron FDA decision, the biotech gets snapped up by Sumitovant Biopharma

November 13, 2020

Via: FierceBiotech

Urovant began life as an offshoot of Vivek Ramaswamy’s Roivant goliath, but is now firmly a part of the Sumitovant Biopharma family after the life science company bought up the rest of its shares in the biotech. This comes around […]


FDA, Regulations

FDA grants emergency authorisation to Lilly’s COVID-19 antibody

November 11, 2020

Via: Pharma Times

Bamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation. In a statement, Lilly […]


Clinical Trials, FDA, Regulations, Research and Development

FDA authorizes first test that screens for Covid-neutralizing antibodies

November 6, 2020

Via: CNBC

The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection. Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long […]


FDA, Regulations

Biogen hits snag after Alzheimer’s drug fails to win support from FDA panel

November 6, 2020

Via: CNBC

A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen’s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company. In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that […]


FDA, Regulations

FDA Places New CMC Demands on bluebird’s Sickle Cell Treatment

November 5, 2020

Via: BioSpace

Shares of bluebird bio fell more than 17% in premarket trading after the company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration (FDA) for two more […]


FDA, Regulations

FDA Awards Fast Track Designation to Multiple Non-COVID-19 Candidates

November 4, 2020

Via: BioSpace

While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. Food and Drug Administration (FDA) has remained busy lining up potential approvals of medications for other diseases and illnesses. Many of these […]


FDA, News, Regulations

FDA staff resist executive order amid fears Trump could reshape agency: report

November 3, 2020

Via: FierceBiotech

FDA officials are pushing back against an executive order that will make it easier for President Donald Trump to fire federal employees, according to a report in Politico. Patrizia Cavazzoni, the acting head of the FDA’s drug center, is reportedly […]


FDA, Regulations

Spectrum Pharmaceuticals Sees Delay from FDA on Eflapegrastim BLA

October 26, 2020

Via: BioSpace

Spectrum Pharmaceuticals announced today that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration (FDA) can approve its Biologics License Application (BLS) for ROLONTIS (eflapegrastim). Because of the COVID-19 pandemic, […]


Clinical Trials, FDA, Regulations, Research and Development

Alnylam makes case for lumasiran in infants ahead of FDA ruling  

October 23, 2020

Via: FierceBiotech

Alnylam has shared data from a phase 3 trial of its near-approval kidney disease drug lumasiran in children as young as three months. The RNAi therapy drove a 72% reduction in urinary oxalate from baseline, boosting Alnylam’s hopes of using […]


FDA, Regulations

FDA blasts another US drugmaker for faulty quality controls on now-recalled thyroid meds

October 21, 2020

Via: FiercePharma

The COVID-19 pandemic has put a damper on the FDA’s on-site inspections in 2020, but that doesn’t mean the agency isn’t making the rounds and putting drugmakers on notice. A second U.S. company making prescription thyroid meds is on the […]