https://www.streetwisereports.com/article/2025/10/06/new-drug-for-duchenne-muscular-dystrophy-nears-potential-approval.html
Capricor Therapeutics Inc. (CAPR:NASDAQ) could receive a PDUFA date for its cell therapy as early as spring 2026 if it follows the FDA-outlined path forward,...
duchenne muscular dystrophynew drugpotentialapproval
https://www.jnj.com/media-center/press-releases/janssen-submits-new-drug-application-to-u-s-fda-seeking-approval-of-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-for-treatment-of-patients-with-pulmonary-arterial-hypertension-pah
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved,...
new drug applicationjanssensubmitsfdaseeking
https://www.thehansindia.com/life-style/health/apex-laboratories-gets-approval-for-clevira-as-covid-supportive-drug-683323
City based pharma company Apex Laboratories will take the doctor's prescription route for its oral antiviral CleVira tablet that got the Central government's...
apexlaboratoriesgetsapprovalcovid
https://reports.statnews.com/collections/all-reports/products/speed-and-safety-fdas-drug-approval
Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency...
drug approvalguidefdapathways
https://yseop.com/news-and-press-releases/yseops-ai-powered-augmented-analyst-chosen-by-lilly-to-expedite-the-drug-approval-process-and-deploy-automation-at-scale/
May 25, 2023 - The Unique Collaboration includes a Long-Term Commercial and Investment Agreement Between Yseop and Lilly, an Industry First for Natural Language Generation...
yseopaipoweredaugmentedanalyst
https://www.labiotech.eu/in-depth/mash-candidates-make-a-splash-after-first-drug-approval/
May 2, 2025 - Rezdiffra, the first drug approved to treat MASH, was approved this year. Recent advancements offer new hope to patients.
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https://newatlas.com/cancer/cancer-drug-fda-approval/
Hugely promising cancer immunotherapy drug dostarlimab is one step closer to being widely available, after the Food and Drug Administration granted it...
cancer drugfda approvalsuccessfulgetslandmark
https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/
Jul 31, 2023 - When Aduhelm’s prospects appeared dead, Biogen mounted a secret campaign to resurrect the drug and convince the FDA to approve it.
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https://med.stanford.edu/news/all-news/2025/08/blood-cancer-drug.html
Fewer than half of people diagnosed with a subtype of myeloid/lymphoid neoplasms are alive one year later. A multicenter Phase 2 trial led by Stanford Medicine...
stanford medicineleads tofda approvalledtrial
https://www.fiercebiotech.com/regulatory/amgen-s-first-class-oncolytic-drug-wins-fda-approval-combo-studies-on-deck
Amgen won a landmark approval for a re-engineered virus designed to fight skin cancer, preparing to launch a first-of-its-kind therapy that could star in...
in classfda approvalamgenfirstoncolytic
https://www.pymnts.com/cpi-posts/pfizer-seeks-to-delay-approval-of-generic-version-of-heart-drug/
Aug 14, 2023 - US pharma giant Pfizer and the Scripps Research Institute filed a patent infringement lawsuit against generic drug maker Dexcel Pharma Technologies. The
generic versionpfizerseeksdelayapproval
https://www.biopharmadive.com/news/fdas-rapid-review-pace-nets-an-early-approval-for-alnylams-second-drug/567754/
Givosiran, which will be sold as Givlaari, is the second RNAi therapeutic cleared by the agency after Alnylam's Onpattro.
fdarapidreviewpacenets