vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes
Cadisegliatin has the potential to be the first oral adjunct therapy for type 1 diabetesCATT1 Phase 3 trial expected to resume following ...
Scholar Rock SMA drug shows muscle function benefit
Scholar Rock’s spinal muscular atrophy (SMA) therapy has shown benefit in muscle function in children under 12 in a pivotal ...
GRIN Therapeutics Receives FDA Orphan Drug Designation for Radiprodil for the Treatment of GRIN-Related Neurodevelopmental Disorder
GRIN Therapeutics, Inc., a leader in the development of therapies to treat serious neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug ...
WPEC CBS 12 on MSN1d
2 guilty of fraud during clinical trials of asthma drugs
The owners of a Pembroke Pines-based medical research facility pleaded guilty Monday to charges they faked information around ...
Clinical Trials Arena on MSN11d
FDA puts clinical hold on BioNTech’s malaria vaccine trial
The FDA has ordered BioNTech to immediately halt its Phase I/II trial of malaria vaccine candidate BNT165e, pending changes.
Travere Therapeutics submits sNDA to FDA for approval of FILSPARI in FSGS
Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...
Medical clinic owners plead guilty in connection to fraudulent clinical drug trials
The business conducted clinical trials of new potential drug treatments on behalf of sponsor companies seeking approval from ...
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FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human ...
Nonalcoholic Steatohepatitis Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
Promising Nonalcoholic Steatohepatitis Therapies such as AZD2693, Saroglitazar Magnesium 4 mg, Semaglutide (SEMA), Cilofexor ...
Melanoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
Melanoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or ...