Biotecnología
Biotecnología
Guidance Snapshot Pilot
05/06/2023 -
Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents...
3M Invests $146M in Biopharma Filtration Technology
05/06/2023 -
Will include facility and equipment improvements and the addition of 60 full-time positions in 3M manufacturing facilities in Europe.
Azmedicinalshop.com - 111111 - 03/27/2019
05/06/2023 -
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
FDA Approves Pfizer’s ABRYSVO Vax for RSV Prevention
05/06/2023 -
Decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 participants.
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information
05/06/2023 -
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information
Rentschler Biopharma, Ikarovec Partner on Gene Therapies for Ophthalmic Disease
05/06/2023 -
Rentschler will support the bioprocess development of AAV material for planned preclinical testing of Ikarovec’s novel gene therapy.
ClearPoint Neuro, UCB Enter License Agreement for Gene Therapy Drug Delivery
05/06/2023 -
UCB will utilize ClearPoint Neuro’s technology and services in connection UCB’s gene therapy products.
FujiFilm Cellular Dynamics Launches Human iPSC-derived Blood-Brain Barrier Isogenic Kit
05/06/2023 -
The first-of-its-kind kit models the human blood-brain barrier and can advance drug discovery and drug development.
Croda, Botanical Solution Partner on Sustainable Vaccine Adjuvant QS-21
05/06/2023 -
The two organizations share expertise to bring to market QS-21 from Quillaja saponaria plant cell culture.
Lotus Clinical Research, Veeva Expand Partnership to Accelerate Clinical Trials
05/06/2023 -
Builds on Lotus' existing use of Vault Clinical Suite to implement swifter and more connected studies.
UCB, Veeva Partner to Advance Clinical Trial Efficiency
05/06/2023 -
Will focus on technology-driven solutions aimed at improving the patient experience and trial efficiency.
GeoVax, ABL Partner to Advance cGMP Production of Vaccine Candidates
05/06/2023 -
With cGMP facilities located in the U.S. and Europe, ABL will support GeoVax’s global development programs.
TriLink BioTechnologies Expands mRNA Manufacturing Facility
05/06/2023 -
GMP facility expected to simplify the mRNA drug substance development process.
Drug Shortages with CDR Emily Thakur
05/06/2023 -
In this podcast series, we answer some of the most frequently asked questions we’ve received from the public.
Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss
05/06/2023 -
FDA has received adverse event reports after patients used compounded semaglutide.
Innovent Enters into Clinical Trial Collaboration with Merck KGaA
05/06/2023 -
Innovent will conduct a Phase 1b study to evaluate the anti-tumor activity and safety of the combination therapy of IBI351(GFH925) with cetuximab.
Ongoing | Non-malignant Hematology, Neurological Disorders, and Other Indications Accelerated Approvals
05/06/2023 -
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment
05/06/2023 -
Draft Guidance Clinical / Medical
Verified Clinical Benefit | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
05/06/2023 -
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
FDA and Kratom
05/06/2023 -
The U.S. Food and Drug Administration is warning consumers not to use <i>Mitragyna speciosa</i>, commonly known as kratom, a plant which grows naturally in Thailand,...
JSR Life Sciences Consolidates KBI Biopharma and Selexis SA
05/06/2023 -
KBI’s new model aims to enhance operational efficiencies, drive strategic clarity, and accelerate innovation for global biopharma customers.
