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RSS FeedPosted by Michael Wonder on 04 Jan 2023
Orasis Pharmaceuticals submits new drug application for investigational novel eye drop candidate, CSF-1, for the treatment of presbyopia
3 January 2023 - Phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary and key secondary ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 02 Jan 2023
With FDA accelerated approval of Alzheimer’s drug lecanemab likely 6 January, discussion turns to price and reimbursement
2 January 2023 - Lecanemab’s PDUFA date for its potential accelerated approval is 6 January. ...
Posted by Michael Wonder on 02 Jan 2023
A new weight loss drug could become the best-selling drug of all time. Who can afford it?
1 January 2023 - An Eli Lilly drug if approved for weight loss could become the best selling drug of ...
Posted by Michael Wonder on 30 Dec 2022
FDA approves once weekly Wegovy injection for the treatment of obesity in teens aged 12 years and older
24 December 2022 - New indication based on clinical trial that demonstrated a 16.1% reduction in body mass index (BMI) in ...
Posted by Michael Wonder on 30 Dec 2022
MediWound announces FDA approval of NexoBrid for the treatment of severe thermal burns in adults
29 December 2022 - Triggers $7.5 million milestone payment from Vericel Corporation; NexoBrid is anticipated to be commercially available in the ...
Posted by Michael Wonder on 30 Dec 2022
Heron Therapeutics announces filing of an efficacy supplement for Zynrelef and provision in newly passed congressional bill anticipated to provide separate reimbursement outside of the packaged surgical payment for Zynrelef
29 December 2022 - Supplemental new drug application submitted requesting expansion of indication to broadly cover soft tissue and orthopaedic surgical ...
Posted by Michael Wonder on 29 Dec 2022
Congressional report: US FDA broke own protocols in approving Biogen Alzheimer's drug
29 December 2022 - The US FDA failed to adhere to its own guidance and internal practices during the approval ...
Posted by Michael Wonder on 29 Dec 2022
TG Therapeutics announces FDA approval of Briumvi (ublituximab-xiiy)
28 December 2022 - US commercial launch expected Q1, 2023. ...
Posted by Michael Wonder on 27 Dec 2022
SpringWorks Therapeutics completes submission of new drug application to the FDA for nirogacestat for the treatment of adults with desmoid tumours
27 December 2022 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application ...
Posted by Michael Wonder on 27 Dec 2022
Acer Therapeutics and Relief Therapeutics announce US FDA approval of Olpruva for patients with urea cycle disorders
27 December 2022 - New FDA approved formulation for patients living with urea cycle disorders. ...
Posted by Michael Wonder on 27 Dec 2022
New FDA guidance explains that Plan B is not an abortion pill
23 December 2022 - The FDA on Friday altered the language attached to emergency contraceptive pills to clarify that they ...
Posted by Michael Wonder on 27 Dec 2022
Harm Reduction Therapeutics' new drug application for RiVive over the counter naloxone nasal spray accepted and granted priority review by FDA
26 December 2022 - Low cost, over the counter naloxone nasal spray advances to FDA review. Approval would increase access ...
Posted by Michael Wonder on 26 Dec 2022
Junshi Biosciences and Coherus share update on the FDA review of the biologics license application for toripalimab as treatment for recurrent or metastatic nasopharyngeal carcinoma
25 December 2022 - FDA has been unable to travel to China to conduct the required site inspection resulting in delayed ...
Posted by Michael Wonder on 24 Dec 2022
Intercept resubmits new drug application to US FDA for obeticholic acid in patients with liver fibrosis due to NASH
23 December 2022 - New drug application supported by robust NASH clinical development program, including two positive interim analyses from the ...