PBAC Public Summary Documents - November 2020 meeting

5 March 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the November 2020 PBAC ...

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Vetex Medical receives FDA clearance for Revene thrombectomy catheter

1 March 2021 - Patented dynamic cage technology designed to predictably remove wall-adherent clot in peripheral veins, such as deep ...

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Agios submits supplemental new drug application to FDA for Tibsovo (ivosidenib) for patients with previously treated IDH1 mutant cholangiocarcinoma

1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA ...

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PLx Pharma receives FDA approval of SNDAs for both Vazalore 325 mg and 81 mg

1 March 2021 - Vazalore is the first ever liquid-filled aspirin capsule with an innovative delivery platform indicated as a pain ...

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Vascular Graft Solutions wins FDA approval to Market the VIOLA clampless proximal anastomosis system for CABG

1 March 2021 - Vascular Grafts Solutions announced today receipt of marketing clearance from the FDA for the VIOLA, a new ...

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U.S. FDA accepts Merck’s gefapixant new drug application for review

1 March 2021 - Application for orally administered selective P2X3 receptor antagonist based on findings from two Phase 3 trials in ...

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Avadel Pharmaceuticals announces FDA acceptance of new drug application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy

1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021. ...

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CorMedix receives complete response letter from FDA for DefenCath catheter lock solution

1 March 2021 - CorMedix announced today that the US FDA cannot approve the new drug application for DefenCath (taurolidine/heparin catheter ...

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Athenex receives FDA complete response letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer

1 March 2021 - Athenex today announced that the U.S. FDA has issued a complete response letter for the company’s ...

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Rare Disease Day 2021: FDA shows sustained support of rare disease product development during the public health emergency

1 March 2021 - Rare Disease Day is a time to reflect on both the progress that has been made, and ...

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LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa

1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...

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Review asks how Government can get the new drugs it wants funded

2 March 2021 - The much-vaunted PHARMAC inquiry, being announced today, will investigate how the drug-buying agency can be brought ...

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Nusinersen in spinal muscular atrophy: indication of considerable added benefit in children with an early onset of the disease

1 March 2021 - The treatment delays permanent ventilation of the children and extends life. In addition, the children develop more ...

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Dapagliflozin in chronic heart failure: hint of added benefit

1 March 2021 - Diabetes drug is also effective in symptomatic chronic heart failure with reduced pump function. However, the additional ...

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FDA authorises first robotically assisted surgical device for performing transvaginal hysterectomy

1 March 2021 - The U.S. FDA has authorised marketing of the Hominis Surgical System, a new robotically-assisted surgical device that ...

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FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

26 February 2021 - Today the FDA granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone ...

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