Immunization Labelling Pharmaceutical Companies 
Pharmacy Times
JUNE 23, 2025
Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.
BioPharma Dive
JULY 16, 2025
The company also paused a study meant to confirm Elevidys’ benefits in these patients, and convert the therapy’s current “accelerated” approval in these patients to a traditional one. Sarepta is working on a new regimen of immune-suppressing drugs to manage the safety risks, and plans to soon share its findings with the FDA.
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BioPharma Dive
JUNE 11, 2025
Based on conversations with physicians, it “could be positioned well, and ahead of Augtyro,” he wrote, adding that Wednesday’s sell off in shares was “overdone on any potential launch and label optics concerns.” Track the deals that are happening here. Sanofi’s $9.1 Track the deals that are happening here. Sanofi’s $9.1
Pharmaceutical Business Review
JUNE 19, 2025
The application is underpinned by the multi-centre, open-label Phase III UNITI-Jr clinical trial data, which assessed the therapy’s safety, pharmacokinetics, and efficacy in paediatric subjects. The company noted that in the US, there are around one million individuals with CD, and children constitute up to 25% of this group.
pharmaphorum
FEBRUARY 9, 2022
The oncology segment has been recognised as one of the most productive areas for pharmaceutical companies to focus their R&D investment. Using a vaccine to utilise the patient’s own immune system to fight cancer is particularly attractive because of the targeted approach made possible by this technology. A broad front.
The Thyroid Pharmacist
NOVEMBER 29, 2023
This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 290 expiring in April 2025.)
European Pharmaceutical Review
AUGUST 14, 2023
Swedish pharmaceutical company Vicore Pharma is developing treatments for diseases where the angiotensin II type 2 receptor (AT2R) has a central role in stopping and reversing disease pathology and where there is a large unmet medical need. The company’s lead candidate, C21, is an angiotensin II type 2 receptor agonist (ATRAG).
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