Italy, EU refuse AstraZeneca request to ship 250,000 doses of vaccine to Australia

5 March 2021 - Italy and the European Union have blocked a shipment of the Oxford-AstraZeneca coronavirus vaccine destined for Australia ...

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EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...

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Government announces review into PHARMAC

2 March 2021 - The Government is following through on an election promise to conduct an independent review into PHARMAC, ...

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GC Pharma submits biologics license application to US FDA for immune globulin 'GC5107'

25 February 2021 - Submission for entering the world’s largest US marketplace. ...

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Medicines New Zealand supportive of Government’s PHARMAC review assuming it is not a box-ticking exercise

2 March 2021 - Medicines New Zealand is supportive of the proposed review into PHARMAC if it is intended to improve ...

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Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH

1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...

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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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