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Pharmabiz50m
US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test
US FDA grants Breakthrough Device Designation to Mursla Bio’s EvoLiver test: Cambridge, UK Friday, April 25, 2025, 17:00 Hrs [IST] Mursla Bio, a leader in Extracellular Vesicle ...
Akeso, Inc.: Akeso Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) ...
Medscape4h
UK Approves Marstacimab for Severe Haemophilia A or B
The UK medicines regulator has approved Pfizer’s marstacimab for patients aged 12 years or older with severe haemophilia A or B, offering a new subcutaneous treatment option.
Mississippi Valley Publishing7h
FDA seeks to phase out 8 common food dyes
Trump administration health officials announced Tuesday they hope to eliminate eight petroleum-based synthetic dyes from the nation’s food supply before the end of next year, though they haven’t ...
Vietnam Investment Review on MSN7h
FDA Approves Akeso s Penpulimab for Dual Use in Nasopharyngeal Cancer Treatment
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in ...
Dr. Reddy’s Looks Well Positioned for Long-Term Growth, Aided by Acquisitions and Partnerships
Besides generics, Dr. Reddy’s has committed a lot of resources to develop its biosimilars as well as new chemical entity business. Biosimilars have been seen as a growth engine for large, capable ...
As FDA delays Novavax' COVID vaccine approval, patients fight back
Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...
Novavax shares soar after FDA request raises hope for COVID vaccine approval
Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...
Medical Marketing & Media1d
With Dr. Marty Makary in power, the FDA’s future comes slightly more into view
Following massive layoffs and cuts at the FDA, Makary’s plan for the agency is yet to fully unfold. But he has hinted at what ...
JD Supra1d
Charting a Conditional Approval Pathway for Rare Disease Drugs - A Top Priority for a Revamped FDA?
Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. Commissioner Makary’s comments build on sentiments expressed across both the patient community and ...
FDA asks Novavax for post-approval data on COVID vaccine, raising hopes for green light
Novavax said on Wednesday the U.S. Food and Drug Administration had asked the company to produce more data on its COVID-19 ...