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RSS FeedPosted by Michael Wonder on 19 Jul 2022
Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream for the treatment of vitiligo
18 July 2022 - Phase 3 data supporting the approval show treatment with Opzelura resulted in improvements in facial and total ...
Posted by Michael Wonder on 18 Jul 2022
Celcuity announces FDA breakthrough therapy designation for gedatolisib for treatment of HR positive, HER2 negative metastatic breast cancer
18 July 2022 - Celcuity today announced that the U.S. FDA has granted gedatolisib breakthrough therapy designation for the treatment of ...
Posted by Michael Wonder on 18 Jul 2022
Mycovia Pharmaceuticals announces U.S. availability of Vivjoa (oteseconazole) capsules, the first and only FDA approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection)
18 July 2022 - Vivjoa is now available in a network of partner pharmacies that includes mail order and local pickup ...
Posted by Michael Wonder on 18 Jul 2022
Acadia Pharmaceuticals submits new drug application to the U.S. FDA for trofinetide for the treatment of Rett syndrome
18 July 2022 - Acadia Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 18 Jul 2022
Renuvion cleared by FDA for neck laxity procedures offering patients a minimally invasive option to eliminate sagging neck
18 July 2022 - Exclusive Apyx Medical device delivers state of the art plasma energy to improve appearance of loose ...
Posted by Michael Wonder on 18 Jul 2022
Azurity Pharmaceuticals announces FDA approval of Zonisade (zonisamide oral suspension)
18 July 2022 - The first and only FDA approved zonisamide oral liquid formulation. ...
Posted by Michael Wonder on 18 Jul 2022
Relief Therapeutics announces that its collaboration partner has resubmitted the ACER-001 (sodium phenylbutyrate) new drug application to the FDA for the treatment of urea cycle disorders
18 July 2022 - Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral ...
Posted by Michael Wonder on 14 Jul 2022
Marinus Pharmaceuticals sells rare paediatric disease priority review voucher for $110 million
14 July 2022 - Marinus Pharmaceuticals today announced that it has entered into a definitive agreement to sell its rare ...
Posted by Michael Wonder on 14 Jul 2022
FDA clears DyAnsys neurostimulation device first relief to treat diabetic neuropathic pain
14 July 2022 - First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US FDA for ...
Posted by Michael Wonder on 14 Jul 2022
FDA approves crizotinib for ALK positive inflammatory myofibroblastic tumour
14 July 2022 - On 14 July 2022, the FDA approved crizotinib (Xalkori, Pfizer) for adult and paediatric patients one ...
Posted by Michael Wonder on 14 Jul 2022
BeiGene provides regulatory update on the U.S. biologics license application for PD-1 inhibitor tislelizumab in second-line oesophageal squamous cell carcinoma
14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...
Posted by Michael Wonder on 14 Jul 2022
FDA grants Alpheus Medical orphan drug and fast track designations for novel sonodynamic therapy for brain cancer
13 July 2022 - The company is currently enrolling patients in a multicentre Phase 1 clinical trial for the treatment ...
Posted by Michael Wonder on 13 Jul 2022
FDA authorises emergency use of Novavax COVID-19 vaccine, adjuvanted
13 July 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Novavax COVID-19 vaccine, adjuvanted for the ...
Posted by Michael Wonder on 13 Jul 2022
Accelerating pooled licensing of medicines to enhance global production and equitable access
8 July 2022 - From October to November, 2021, the pharmaceutical firms Merck and Pfizer licensed their new COVID-19 oral antiviral ...
Posted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...