Targeted Oncology1d
FDA Clears Investigational New Drug Application for CD-001 in Oncology
Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.
ThePrint on MSN4d
Why Indian patients groups are opposing patent requests for blockbuster HIV drug lenacapavir
Granting patents to US firm Gilead Sciences for lenacapavir could hinder global efforts to end AIDS & restrict access to ...
Cure Today13d
FDA OKed New Drug Application for Novel Glioblastoma Treatment
The Food and Drug Administration (FDA) has cleared an investigational new drug application for the novel treatment, APTN-101, ...
Twice-a-year injection reduced risk of HIV infection by 96%, drug company says — more than daily PrEP pill
A drug currently used to treat HIV has also been found to dramatically reduce the risk of infection, significantly more than the primary option available for pre-exposure prophylaxis or PrEP.
Yahoo Finance25d
FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN
has accepted the Company’s New Drug Application (NDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis type 1 ...
FierceBiotech4d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
adaptive behavior and tremor” and went ahead with filing a new drug application with the FDA. Applied had planned to ask for U.S. approval on the strength of biomarker data, only for the FDA to ...
The Hindu4d
Patent applications for HIV prevention drug opposed in India
Sankalp, a civil society organisation working with populations vulnerable to HIV, opposed the patent applications stating ... According to UNAIDS, this new HIV drug can offer hope of ending ...
The Jamaica Observer11d
Indies Pharma gets FDA approval on new drug
Indies Pharma Jamaica Limited has made history as it became the first Jamaican company to get an ANDA (Abbreviated New Drug Application) approved by the United States Food and Drug Administration ...
Medscape2d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
Purpose: The revised prescription drug labeling ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug ...
National Academies of Sciences%2c Engineering%2c and Medicine10d
To Increase Pace and Volume of Drug Approvals for Rare Diseases, Report Recommends FDA Enhance Information Sharing, Improve Collaboration
The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and world. Our ...
News Medical on MSN3d
New kidney chip offers breakthrough for drug development and personalized medicine
Developing advanced drug screening tools is crucial for the advancement of personalized medicine and the creation of more effective treatments. One organ receiving particular attention in this area is ...
Morningstar19d
KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema
has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult ...