FDA Archives - histarmar

03/02/2021

AstraZeneca, FibroGen: FDA To Convene Committee Meeting To Review Roxadustat In Anaemia Of CKD

AstraZeneca Plc. (AZN.L,AZN) announced Tuesday that the US Food and Drug Administration or FDA informed FibroGen, Inc. that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory

03/02/2021

FDA Says No To ATNX And CRMD, Morphic Jumps On IBD Trial Data, INO’s REVEAL 1 Meets Goals

Today’s Daily Dose brings you news about the regulatory set back of Athenex’s oral Paclitaxel and CorMedix’s Defencath, ASLAN Pharma’s Atopic Dermatitis trial results, FDA panel review of FibroGen’s Roxadustat,

02/12/2021

NDAL MFG Recalls Manukaguard Allercleanse Nasal Spray

NDAL MFG Inc. called back one lot of Manukaguard Allercleanse nasal spray citing yeast contamination, the U.S. Food and Drug Administration said in a statement. The spray is used to

02/08/2021

Nine Firms Issued Warning Letters Against Selling Unauthorized E-liquids

The U.S. Food and Drug Administration (FDA) has issued warning letters to nine firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids. The move

02/05/2021

Novavax Does It Again!

Shares of Novavax Inc. (NVAX) set a fresh record high of $235.50 on Friday as investors cheered the company’s coronavirus vaccine trial results. The company’s protein-based COVID-19 vaccine candidate, NVX-CoV2373,

01/27/2021

ACRS Soars On RA Trial Data, BHVN Disappoints In Alzheimer’s Trial, GRTS Joins COVID-19 Vaccine Race

Today’s Daily Dose brings you news about another Alzheimer’s disease drug failure, encouraging data of Aclaris’ rheumatoid arthritis trial; Royalty Pharma/Minerva deal; Gritstone joining the COVID-19 vaccine race; and FDA

12/24/2020

FDA Panel Recommends Emergency Use Of Moderna’s COVID-19 Vaccine

The U.S. Food and Drug Administration’s vaccine advisory committee has recommended the emergency use of Moderna’s COVID-19 vaccine candidate mRNA-1273. If authorized, it would be the second COVID-19 vaccine available

12/23/2020

CYCC Gets $7Mln Strategic Investment, SUPN Abuzz, SNGX Plunges On Oral Mucositis Trial Data

Today’s Daily Dose brings you news about BioCryst’s update on its investigational broad-spectrum antiviral Galidesivir in the treatment of COVID-19, a $7 million strategic investment by Acorn Bioventures in Cyclacel

12/15/2020

The FDA has approved the first genetically modified pig for people with meat allergies

The FDA has approved a genetically modified pig for both human consumption and medicinal purposes. The pigs lack alpha-gal sugar, which causes an allergic reaction in those who have alpha-gal

12/03/2020

BCRX Awaits FDA Decision, JNJ On Watch, Pfizer/BioNTech’s COVID-19 Vaccine Gets Green Light In UK

Today’s Daily Dose brings you news about the UK authorizing Pfizer/BioNTech’s COVID-19 mRNA vaccine BNT162b2 for emergency use, the anticipated event of BioCryst Pharma, Janssen acquiring rights to investigational gene