Category - Developments

Developments

NRx Pharmaceuticals submits IND for chronic pain

NRx Pharmaceuticals (NASDAQ:NRXP) submitted an investigational new drug (IND) application to the FDA for the use of NRX-101 to treat chronic pain. The IND application leverages pioneering research on the use of D...

August 30, 2023

Developments

Outlook Therapeutics receives CRL in wet AMD

Outlook Therapeutics (NASDAQ:OTLK) received a complete response letter (CRL) to the company’s biologics license application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development...

August 30, 2023

Developments

Zealand Pharma gets FDA priority review in congenital hyperinsulinism

The FDA granted priority review designation for Zealand Pharma’s (NASDAQ:ZEAL; CVR-no. 20045078) dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with...

August 30, 2023

Developments

AEON presents positive Phase results in cervical dystonia

AEON Biopharma (NYSE:AEON) presented positive results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the...

August 29, 2023

Developments

Anixa Biosciences treats third patient in ovarian cancer CAR-T clinical trial

Anixa Biosciences (NASDAQ:ANIX), in partnership with Moffitt Cancer Center, commenced treatment of the third patient in the ongoing clinical trial of Anixa’s novel chimeric antigen receptor T-cell (CAR-T) therapy...

August 28, 2023

Developments

ANI Pharma announces FDA approval and launch of Estradiol Gel, 0.1%

ANI Pharmaceuticals (NASDAQ:ANIP) received FDA approval for the abbreviated new drug application for Estradiol Gel, 0.1%, to treat and prevent hot flashes. ANI’s Estradiol Gel, 0.1%, is the generic version of the...

August 28, 2023

Developments

XyloCor presents positive Phase 2 data for refractory angina

XyloCor Therapeutics presented positive results from the Phase 2 portion of its Phase 1/2 EXACT clinical trial of its lead gene therapy candidate, XC001, for the treatment of refractory angina at the European Society of...

August 25, 2023

Developments

SK bioscience, Vaxxas in pact for needle-free patch delivery of typhoid vaccine

SK bioscience of South Korea entered into a collaboration agreement with Australia’s Vaxxas to develop a second-generation typhoid conjugate vaccine with support from Wellcome, a global charitable foundation supporting...

August 24, 2023

Developments

EMA accepts Novaliq’s CyclASol for regulatory review in DED

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) from Novaliq GmbH for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new...

August 24, 2023

Developments

Tarsier Pharma misses endpoint in Phase 3 uveitis trial

Closely-held Tarsier Pharma of Israel did not reach the primary endpoint in the non-infectious anterior uveitis TRS4VISION trial with its TRS01 eye drops. However, a post hoc analysis of the data demonstrates the much...

August 23, 2023

Category - Developments

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