Unicycive: FDA to Review Lead Drug Candidate for Hyperphosphatemia
Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...
GEN4d
Parallel Platform Approach Slashes Process Development Time
Since risk comes from decisions on limited information, Pheast builds in flexibility to adjust processes as information becomes available.
Physicians Committee4d
Innovative FDA Program to Evaluate Nonanimal Organ-on-a-Chip Technology
In an exciting development for drug development and patient care, the FDA has officially accepted the first submission of an organ-on-a-chip technology under its Innovative Science and Technology ...
news24online6d
Strategic Leadership In Pharmaceutical Regulatory Affairs: The Innovative Approach Of Mitul Tilala
By thoroughly analyzing CMC processes, Mitul Tilala ensures each step is carefully evaluated to identify any areas of concern ...
Impacts7d
How We Get New Medicines: The Journey From a Scientist’s Idea to a Life-Saving Drug
The path from a scientist’s initial idea to a new medicine that can save lives is a complex and often lengthy process. It ...
News Medical10d
New technology streamlines drug discovery using single-molecule tracking
New drug discovery is a critical step for improving patients' lives. First, researchers must identify molecules in the body's cells that help drive disease, as these are potential targets for new ...
Appili Therapeutics Announces Alignment with FDA on Development Requirements for ATI-1801 Topical Antiparasitic Product NDA Submission
Demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studiesAppili provides update on Aditxt transaction and encourages ...
FiercePharma13d
Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'
As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. | Novartis didn't use a priority review voucher for Pluvicto's key ...
Healthcare Dive14d
5 steps to navigate the FDA’s new lab developed test rule
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five ...
Reuters14d
Novartis to pay Monte Rosa $150 million upfront to develop a new class of drugs
Oct 28 (Reuters) - Swiss pharmaceutical giant Novartis (NOVN.S), opens new tab will pay Monte Rosa ... manufacture and sell some drug candidates, the U.S.-based biotech firm said on Monday.
Channel NewsAsia Singapore14d
Olympus says CEO steps down after allegations of illegal drug purchase
TOKYO :Japanese medical equipment maker Olympus Corp said on Monday that Chief Executive Stefan Kaufmann has stepped down after allegations he purchased illegal drugs, sending its shares sharply ...
Investing14d
Olympus CEO ousted after allegation of illegal drug purchase, shares slump
TOKYO (Reuters) -Japanese endoscope manufacturer Olympus Corp said on Monday it has sacked Chief Executive Stefan Kaufmann after an allegation that he had purchased illegal drugs, sending its ...