New nasal vaccine for COVID-19 set to begin clinical trial in the U.S.
A nasal vaccine for COVID-19 – based on technology developed at Washington University in St. Louis – is poised to enter a phase 1 clinical trial in the U.S. after an investigational new drug ...
The Bakersfield Californian10d
Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to ...
has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled ...
COUR Pharmaceuticals Secures FDA Clearance of IND Application for CNP-103 in Type 1 Diabetes
The Phase 1b/2a study will assess the safety of CNP-103 in adults (aged 18-35) and pediatrics (aged 12-17) who have Stage III or newly diagnosed (within the last 6 months) T1D as well as C-peptide ...
Lincoln Journal Star10d
Nebraska startup aims to use milk nanoparticle to improve drug delivery
Minovacca plans to hire UNL students to work on submitting an Investigational New Drug Application to the U.S. Food and Drug Administration, a request to administer an investigational drug to ...
Healio22d
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
Please provide your email address to receive an email when new articles are posted on ... episodes and nighttime blood pressure (BP). The drug’s safety profile in this specific patient ...
Insider Monkey7d
12 Stocks That Will Double in 2025
In the third quarter of 2024, the company announced that five investigational new drug applications cleared across several therapeutic areas and FDA divisions for its leading drug, IMVT-1402.
Human Growth Hormone Market Size is Expected to Reach USD 18.75 Billion by 2033, Growing at a CAGR of 11.90%: Straits Research
The global human growth hormone market size was valued at USD 6.81 billion in 2024 and is projected to reach from USD 7.63 billion in 2025 to USD 18.75 billion by 2033, growing at a CAGR of 11.90% ...
Nature23d
Drug output slows in 2006
The good news is that Investigational New Drug submissions and New Drug Applications continue to be above average, with the latter hitting a high not seen since 1999.
Stockhouse14d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational ... that the U.S. Food and Drug Administration (FDA) has accepted the ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
Targeted Oncology29d
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications. The FDA cleared an ...