FiercePharma2d
Seeking new social media horizons, EMA joins mass migration from X to Bluesky
As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines ...
Managed Healthcare Executive3d
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 ...
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, ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...
JD Supra4d
Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain in Q4/ 2024
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...
EQS-News: Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama®
EQS-News: Formycon AG / Key word (s): Regulatory Approval Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama® 20.01.2025 / ...
GlobalData on MSN9d
FDA beats EMA to most approved new drugs in 2024
On 15 January, the two agencies released respective lists of medicines approved last year. The FDA approved 50 novel drugs ...
Care Quality Commission14d
Time sensitive medicines
Some medicines need to be given at a certain time to make sure they are safe or work effectively. The stomach or intestinal contents can affect the absorption of some medicines. Some medicines need to ...
cybernews16d
European space agency has big ambitions for 2025 but only a "modest budget"
“We are certainly prepared for any scenarios that might come to the table,” Director General of the European Space Agency (ESA) Josef Aschbacher said. “ESA and Europe will be ready to adjust, to find ...
Pharmaceutical Technology19d
EMA gives OMPD to Actuate’s pancreatic cancer therapy
Credit: Jo Panuwat D/Shutterstock. Actuate Therapeutics has gained orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for elraglusib to treat pancreatic ductal ...
Indiatimes24d
Over 250 medicines to cost more from January 1 in the U.S; is your critical drug in the list? Check here
On January 1, pharmaceutical companies will also lower some of their prices. The list price of Merck & Co.'s heavily discounted diabetes medications Januvia and Janumet will be lowered "to align the ...