- Vertex Announces FDA Acceptance of New Drug Application for ...🔍
- ORAL ARGUMENT REQUESTED UNITED STATES DISTRICT ...🔍
- FDA approves treatment for adults with Alzheimer's disease🔍
- CARVYKTI® is the First and Only BCMA|Targeted Treatment ...🔍
- AIDS Activist Takes Up a New Fight🔍
- A Drug by Any Other Name🔍
- FDA Approves ZURZUVAE™ 🔍
- Applied Therapeutics Provides Regulatory Update on Govorestat for ...🔍
Statement from Treatment Action Group on U.S. FDA Approval of ...
Vertex Announces FDA Acceptance of New Drug Application for ...
... U.S. Food and Drug Administration for the treatment of cystic fibrosis. ... The company has approved medicines that treat the underlying causes ...
ORAL ARGUMENT REQUESTED UNITED STATES DISTRICT ...
On December 17, 2014, the Treatment Action Group (“TAG”) and the Global Health ... U.S. Food & Drug ... FDA approval influences treatment options in other nations— ...
FDA approves treatment for adults with Alzheimer's disease
The US Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer's disease.
CARVYKTI® is the First and Only BCMA-Targeted Treatment ...
CARVYKTI® is now approved in the U.S. for the second-line treatment of adult patients with relapsed or refractory myeloma who have received at ...
AIDS Activist Takes Up a New Fight: Defending FDA
Mark Harrington, executive director of the Treatment Action Group, which spun off from ACT UP in the 1990s, says AIDS activists have long tried to distance ...
A Drug by Any Other Name - Treatment Action Group
Securing access to generic drugs to treat HIV, hepatitis C virus (HCV), and tuberculosis (TB) is now one of the most prominent strategies of global health care ...
FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral ...
Additionally, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with ...
Applied Therapeutics Provides Regulatory Update on Govorestat for ...
The Company recently completed its late-cycle review meeting with the United States Food and Drug Administration (FDA). The FDA communicated ...
FDA APPROVES DRUG FOR TREATMENT OF AIDS
The Food and Drug Administration yesterday approved the first new therapy for previously untreated AIDS patients since it endorsed AZT in 1987.
NIH Trial Data Underpins FDA Approval of Omalizumab for Food ...
The trial is called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults, or OUtMATCH.
FDA Lifts Clinical Hold on Investigational Lenacapavir for the ...
In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV infection in heavily ...
Adaptimmune Receives U.S. FDA Accelerated Approval of ...
PHILADELPHIA & OXFORD, England--(BUSINESS WIRE)-- Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of ...
AHA Statement on "Evaluating Approaches to Diagnostic Test ...
We urge Congress to exempt hospitals and health systems from being included in this FDA device framework or help ensure that regulatory ...
Comment from Anonymous - Regulations.gov
Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment ...
FDA Approves Merck's KEYTRUDA® (pembrolizumab) Plus ...
The US Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy,
Blueprint Medicines Announces FDA Approval of AYVAKIT ...
U.S. Food and Drug Administration ( FDA ) has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic ...
FDA Approves PTC Therapeutics' Gene Therapy Kebilidi for AADC ...
The FDA's approval was made based on data from the global phase 1/2 PTC-AADC-GT-002 clinical trial (NCT04903288). The decision was made under an ...
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clinical trials,. U.S. Food and Drug Administration (FDA) authorization or approval, and. development and approval of vaccine recommendations ...
Vertex and CRISPR Therapeutics Announce US FDA Approval of ...
U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 genome-edited cell therapy ...