Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Managed Healthcare Executive8h
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
Monthly Prescribing Reference14h
FDA Extends Review of Elamipretide for Barth Syndrome
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Investing.com -- Shares of Ionis Pharmaceuticals (NASDAQ: IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a ...
ThePrint17h
Indian drugmaker Dr Reddy’s misses Q3 profit view on weak pricing in US
BENGALURU/HYDERABAD (Reuters) -Indian generic drugmaker Dr Reddy's Laboratories reported third-quarter profit below expectations on Thursday, hurt by pricing pressure in the competitive North American ...
Apellis Pharmaceuticals executive sells $33,346 in stock
James George Chopas, Vice President and Chief Accounting Officer of Apellis Pharmaceuticals, Inc. (NASDAQ:APLS), sold 1,096 shares of the company's common stock on January 22, according to a recent ...
Malawi Nyasa Times13h
FDA authorizes marketing of 20 ZYN nicotine pouch products after extensive scientific review
Malawi breaking news publishing 24 hours a day news about Malawi, Malawi Business, Malawi Tourism, Malawi Politics, Malawi News ...
Richmond BizSense23h
Regional pharma manufacturing group secures $4M for workforce development
The grant money will be used to create new degree programs at Reynolds and Brightpoint community colleges to help develop the ...
Marijuana Moment12h
New Nebraska Bills Would Implement—And In Some Cases Restrict—Access To Medical Marijuana Approved By Voters
Our hope is that we’re going to work as fast and as hard as possible to make sure that they can get access to the care that they need.” By Zach Wendling, Nebraska Examiner Three similar legislative ...