News

FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
The Pharma Letter19h
J&J wins FDA approval for Imaavy to treat gMG
The US Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, ...
The Pharma Letter1d
FDA approval for Rinvoq for giant cell arteritis
Chicago-based drugmaker AbbVie has announced the US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), ...
GlobalData on MSN1d
FDA approves Abeona’s $3.1m cell therapy for rare skin disease
Abeona has won FDA approval for Zevaskyn, setting up a commercial challenge to Krystal Biotech in the rare skin disease ...
BioPharma Dive2d
FDA misses approval deadline for biotech’s rare disease drug
The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.
STAT2d
Amid FDA chaos, approval of a rare disease drug gets delayed — again
Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...
Clinical Advisor1d
FDA Denies Approval of Brain Cancer Imaging Agent
TLX101-CDx is an investigational positron emission tomography agent that targets the membrane transport proteins, LAT1 and LAT2.
Roche's Susvimo FDA Approval Marks New Era in Diabetic Macular Edema Treatment Market | DelveInsight
Diabetic macular edema is a complication that develops from diabetic retinopathy, a widespread consequence of diabetes and a ...
Jezebel1dOpinion
Josh Hawley Calls on FDA to Restrict Abortion Pill Based on Bogus ‘Study’ from Right-Wing Org
The Missouri Senator is demanding changes to mifepristone two weeks after his wife's employer launched an attack on birth ...
Fierce Biotech1d
UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
Abeona Therapeutics Wins FDA Approval For First-of-Its-Kind Gene Therapy
FDA approves Zevaskyn as the first cell-based gene therapy for RDEB wounds after strong results in pivotal and long-term studies.
STAT2d
Pharmalittle: We’re reading about FDA chaos delaying a rare disease drug, Merck’s U.S. investment, and more
Merck will grow its U.S. manufacturing footprint with a $1 billion plant, making it the latest drugmaker to invest in the U.S ...