Biotecnología
Biotecnología
NImmune Biopharma Launches with Phase 3-Ready Clinical Candidate Omilancor
23/03/2023 -
The once-daily, oral, gut-restricted therapeutic for Ulcerative Colitis has potentially fast-to-market follow-on opportunities in Crohn’s disease and psoriasis.
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF - 04/12/2023
23/03/2023 -
The GDF is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program.
Enveric Biosciences Creates Australia-based Subsidiary to Accelerate Lead Program
23/03/2023 -
Clinical trial investigating Enveric’s lead product candidate, EB-373 targeting anxiety disorder expected to initiate in the fourth quarter of 2023.
Patient Engagement Collaborative
23/03/2023 -
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient...
Hovione, Ripple Enter Strategic Drug Delivery Pact
22/03/2023 -
Partnership aims to expand the use of Ripple's Epidel platform beyond ophthalmic applications.
Roster of the Allergenic Products Advisory Committee
22/03/2023 -
As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory...
New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
22/03/2023 -
Historically, CBER has regulatory jurisdiction over some NDA products. Most NDAs are reviewed by the Center for Drug Evaluation and Research (CDER). There are only a few ANDAs currently regulated at...
Cellipont Receives Investment from OrbiMed for Commercial Manufacturing Facility
22/03/2023 -
New facility in Texas will have capabilities for process and analytical development and manufacturing services for CAR-T, IPSC, MSC and cell therapies.
Societal CDMO Gets FDA Nod to Manufacture of Commercial Tablet
22/03/2023 -
Represents Societal CDMO’s first commercially manufactured tablet product.
KBI Biopharma Releases Inaugural FIH Manufacturing Batch at Geneva Facility
22/03/2023 -
Milestone affirms KBI and Selexis SA’s Geneva cGMP site is operational and running successfully.
FDA Roundup: March 21, 2023
22/03/2023 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Drug Trials Snapshot: PONVORY
22/03/2023 -
PONVORY is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary...
www.ivermectin4covid.com - 650184 - 03/16/2023
22/03/2023 -
Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne - 639220 - 08/29/2022
22/03/2023 -
Compounding Pharmacy/Adulterated Drug Products
Grand River Aseptic Manufacturing Receives Zero Observations from FDA Inspection
22/03/2023 -
Aiding in the supply of Bavarian Nordic’s JYNNEOS.
Amgen Plans to Cut 450 Jobs
22/03/2023 -
Citing drug pricing pressures and high inflation.
Synthego Unveils CRISPR Discovery Partners to Streamline Drug Research
22/03/2023 -
Partnership network combines the power of automated CRISPR cell line engineering with phenotypic, functional and multi-omic assays to optimize research work.
Project Orbis
22/03/2023 -
Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international...
CDER Conversations
22/03/2023 -
Interviews with FDA scientists regarding current events relating to the FDA.
Syneos Health Partners with Microsoft to Optimize Clinical Trials
22/03/2023 -
Aims to deliver technology and data solutions to help fast-track timelines, optimize resource allocation, and create clinical trial efficiencies.
OpenAI lanza GPT4, el chatbot más potente impulsado por inteligencia artificial
18/03/2023 -
La compañía OpenAI, que adquirió fama con ChatGPT, un chatbot impulsado por inteligencia artificial (IA), ha lanzado GPT-4, una actualización más potente de su modelo anterior que puede...
