Viatris and Kindeva Drug Delivery announce FDA tentative approval of the first abbreviated new drug application generic version of Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

8 March 2021 - Milestone reinforces Viatris' commitment to complex products and innovative solutions to help increase patient access ...

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KemPharm announces FDA approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), a new once daily treatment for ADHD

2 March 2021 - KemPharm today announced that the U.S. FDA has approved the new drug application for Azstarys (formerly referred ...

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Eyenovia announces FDA acceptance of the MydCombi new drug application

2 March 2021 - Eyenovia today announced that the U.S. FDA has accepted the Company’s new drug application for MydCombi, ...

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Proposal to fully fund Mercilon 28 for oral contraception

26 February 2021 - PHARMAC is seeking feedback on a proposal to increase the subsidy to fully fund ethinyloestradiol 20 ...

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Veru submits new drug application for proprietary Tadfin for benign prostatic hyperplasia

23 February 2021 - FDA PDUFA date is expected in December 2021. ...

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ViiV Healthcare submits supplemental new drug application to US FDA for expanded use of Cabenuva (cabotegravir, rilpivirine) as an HIV treatment for use every 2 months

24 February 2021 - ViiV Healthcare announced today the submission of a supplemental new drug application to the US FDA for ...

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Ultragenyx announces approval of Dojolvi (UX007/triheptanoin) in Canada for the treatment of long-chain fatty acid oxidation disorders in adults and children

17 February 2021 - First approved treatment for adult and paediatric patients with long-chain fatty acid oxidation disorders in Canada. ...

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Supplier of expensive cystic fibrosis medication yet to apply for PHARMAC approval

17 February 2021 - Government drug-buying agency PHARMAC has revealed the supplier of expensive cystic fibrosis medicine Trikafta still hasn’t ...

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Novartis Entresto granted expanded indication in chronic heart failure by FDA

16 February 2021 - Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined ...

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Cystic fibrosis advocate asks P.E.I. to fast-track coverage of new 'mind-blowing' drug

10 February 2021 - ‘It’s the closest thing we’ve ever had to a cure’. ...

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Scottish approval of a new treatment for people with chronic obstructive pulmonary disease - formoterol fumarate dihydrate/glycopyrronium bromide/budesonide

8 February 2021 - AstraZeneca today announced that Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is now accepted for use by the SMC ...

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Cystic fibrosis survivor calls for life-saving drug Trikafta to be funded as PHARMAC dangles hope

3 February 2021 - Drug buying agency PHARMAC has revealed it is willing to go directly to the Government for ...

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Chiesi Group receives the European Marketing authorization for the extrafine triple-combination therapy for the treatment of moderate to severe asthma

1 February 2021 - It is the first extrafine fixed triple combination therapy in a single inhaler to be approved for ...

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EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)

1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...

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New Zealand Pharmaceutical Schedule - 1 February 2021

1 February 2021 - The February 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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