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FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Teva's Growth Profile Looks Strong From Innovative Portfolio, Biosimilar Approvals and Deep Pipeline
We assign Teva a Morningstar Uncertainty Rating of High, which largely reflects our quantitative analysis of the firm, based on the return ranges used by our star rating system, as well as our ...
As Trump and RFK Jr. move to upend drug making, Seattle biotech bets on science
Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...
Protheragen Introduces One-Stop Therapeutic Development Solutions to Accelerate Ophthalmic Drug Research
Protheragen launches a full spectrum of ophthalmic drug preclinical R&D services to streamline the complex process of developing effective therapies for eye diseases. Protheragen, a reputable research ...
Targeted Oncology2d
FDA Grants FTD to 64Cu-SAR-bisPSMA for PET Imaging in Prostate Cancer
The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in ...
drugtargetreview.com2d
Obstacles and innovations of macrocyclic drug development
Discover the potential of macrocycles in drug discovery: flexible, cell-permeable molecules targeting undruggable proteins.
Tech-Enabled Health: Revolutionizing The Standard Of Care
This piece is part of a series that dives deeper into the most prevalent themes of this year’s iteration of our flagship research piece, Charting Disruption. Click to read.
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a novel treatment to treat autism spectrum ...
Clarity Pharmaceuticals: Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer
Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to ...
Thailand Business News5d
Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer
Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission ...
Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update
GRAFAPEX™ (treosulfan) for injection is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that ...