This epinephrine sublingual spray is designed for emergency situations. The FDA’s feedback could potentially lead the company to a New Drug Application (NDA) submission. The FDA-approved epinephrine prodrug
The partnership aims to accelerate the development of new treatments for eye diseases (ophthalmology) and cancer (oncology) as well as enhance the technologies for their production. This deal
This collaboration is set to streamline and scale up manufacturing of cell therapies for clinical trials in the future, with financial backing from the European Innovation Council (EIC) Accelerator
The FDA’s ODD status is granted to investigational assets for treating diseases affecting less than 200,000 people in the US. This designation provides incentives such as tax credits for
Denosumab has received approval in several countries and regions under different brand names for multiple indications, including osteoporosis treatment in postmenopausal women at high risk of fractures, among
As per the latest approval, the oral liquid methotrexate drug is intended to treat kids with acute lymphoblastic leukaemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA), JYLAMVO is
The investment round saw contributions from Gimv, HealthCap, Red Tree Venture Capital, and existing backers BioGeneration Ventures, M Ventures, and Brabantse Ontwikkelings Maatschappij (BOM). The funds will be
Dubbed SPRINX-1 Study, the trial aims to assess the safety and efficacy of RXRG001 in treating radiation-induced xerostomia (RIX) [dry mouth] and hyposalivation conditions. A proprietary product created
The acquisition will include ImmPACT’s lead product, IMPT-314, aimed at treating haematologic malignancies, such as large B-cell lymphoma. IMPT-314 is a dual-targeting CAR T-cell product candidate that is
The CRL, dated 22 October 2024, comes ahead of the Generic Drug User Fee Amendments of 2022 (GDUFA) goal date set for 29 October 2024. Ketamine, an essential
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