Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...
Appili Therapeutics announces FDA alignment on ATI-1801 NDA requirements
Appili Therapeutics (APLIF) announced that the U.S. Food and Drug Administration has provided positive feedback regarding the development ...
PharmTech15d
Drug Solutions Podcast: Dosage Forms: Roundtable on Oral Solid Dosage Trends
In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan. Michelle Logan is vice president, ...
Cure Today20d
FDA Accepts New Drug Application for Pixclara for Glioma Imaging
The FDA has accepted a new drug application for the glioma-imaging agent Pixclara, with a decision expected next year. The Food and Drug Administration (FDA) has accepted a new drug application for ...
Financial Post20d
Zymeworks Presents New Preclinical Data on Antibody-Drug Conjugate Programs at EORTC-NCI-AACR Conference
We expect to submit an investigational new drug application (IND) and non-U.S. applications for ZW220 in the first half of 2025. Zymeworks is a global clinical-stage biotechnology company committed to ...
Taiwan News21d
FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
MELBOURNE, Australia, Oct. 24, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has ...
Medical Xpress23d
New CAR-T cells offer on-demand control for cancer treatment
Ludwig Cancer Research scientists have devised new types of chimeric antigen ... able to dimerize the two chains upon application of a cancer drug called venetoclax. When it binds those external ...
Post Register24d
LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment ...
The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. “With the acceptance of our New Drug Application for LNZ100, we are pleased to be one ...
Newsweek25d
Hurricane Oscar Forms: What to Know About New Storm Off the Bahamas
Environmental conditions appear conducive for some additional development over the next day or so, and a short-lived tropical depression or storm could form before the system moves inland over ...
New York Post25d
Homelessness, drug addiction drive public safety concerns in Vermont’s largest — and lefty — city: ‘I don’t walk at night’
Residents and business owners in Burlington, Vermont, spoke to Fox News Digital this week about the challenges their city is facing with an increase in homelessness and drug use on city streets ...
The Hill26d
Drug companies that violate law would fund medical research under new Democratic legislation
Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.) have introduced legislation that would require pharmaceutical companies that have entered settlement agreements over violating ...
The Washington Post27d
New drug overdose data provides hope while deaths remain too high
“This new data shows there is hope, there is progress, and there is an urgent call to action for us all to continue working together across all of society to reduce drug overdose deaths and save ...