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FDA Accepts NDA Resubmission of Rivoceranib and Camrelizumab in HCC
The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic hepatocellular carcinoma is supported by the final survival analysis of CARES-310 trial.
Lenz Therapeutics announces FDA acceptance of NDA for LNZ100
LENZ Therapeutics (LENZ) announced that the U.S. Food and Drug Administration, FDA, has accepted the Company’s New Drug Application, NDA,
LENZ Therapeutics Shares Rise After FDA Accepts Application for Potential Eye Condition Treatment
LENZ Therapeutics shares were up after the company said that the Food and Drug Administration has accepted its new drug application for LNZ100. Shares were up 5% to $29.12 in recent trading. The stock hit its 52-week high of $31 earlier in the session,
6d
on MSN
Experimental ALS drug could offer new hope for patients if approved, researchers say
New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...
News Medical
19h
How to navigate chemistry, manufacturing, and controls (CMC ) challenges in breakthrough drug development
Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.
Cure Today
4d
FDA Accepts New Drug Application for UGN-102 in Bladder Cancer
The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
Monthly Prescribing Reference
4h
Aceclidine-Based Eye Drop Under Review for Presbyopia
LNZ100 is a single-use, once-daily eye drop containing aceclidine, a small molecule acetylcholine receptor agonist that causes miosis.
Zacks.com on MSN
3d
Avadel Obtains FDA Nod for Label Expansion of Narcolepsy Drug Lumryz
Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...
MedPage Today
12d
FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome
In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...
manilatimes
19h
LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia
The NDA submission for the treatment of presbyopia is supported by the positive data results from the pivotal Phase 3 CLARITY study. Aceclidine is a new chemical entity in the United States and is not ...
6d
How Quantum Computing Is Accelerating Drug Discovery And Development
Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. But with ...
3d
on MSN
Ozempic may help battle drug and alcohol addiction
Diet and diabetes drugs like Ozempic and Mounjaro could also help people struggling with alcohol and opioid abuse, according ...
GlobalData on MSN
3d
Intercept’s liver disease drug Ocaliva faces FDA approval delay
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
11d
AI Simulations Help Drug Trials
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...
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LENZ Therapeutics
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