Tags : NDA

Chugai Reports NDA Submission of Risdiplam to the MHLW as

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with […]Read More

Janssen Reports the NDA Submission to the US FDA for

Shots:   The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the […]Read More

Henlius Reports NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Shots: NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent […]Read More

Athena Bioscience’s Qdolo (tramadol hydrochloride) Receives US FDA’s NDA Approval

Shots: Athena Biosciences announced that the US FDA has approved Qdolo (tramadol hydrochloride) oral solution 5mg/1mL C-IV The most common AE’s (≥15.0%) observed in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus Qdolo is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative […]Read More

Bayer Reports the NDA Submission to NMPA for Vericiguat to

Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s […]Read More

BioMarin Reports NDA Submission to the US FDA for Vosoritide

Shots: BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020 Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia […]Read More

G1 Therapeutics Reports the US FDA Acceptance and Priority Review

Shots: The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has demonstrated robust myelopreservation benefits. The company anticipates the PDUFA date as Feb 15, 2021 G1 is making Trilaciclib available to SCLC patients in the US, who are unable to enter […]Read More

Gilead Reports NDA Submission to the US FDA for Veklury

Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, […]Read More