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RSS FeedPosted by Michael Wonder on 08 Mar 2021
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 ...
Posted by Michael Wonder on 03 Mar 2021
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 ...
Posted by Michael Wonder on 02 Mar 2021
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, ...
Posted by Michael Wonder on 01 Mar 2021
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 ...
Posted by Michael Wonder on 25 Feb 2021
Veru submits new drug application for proprietary Tadfin for benign prostatic hyperplasia
23 February 2021 - FDA PDUFA date is expected in December 2021. ...
Posted by Michael Wonder on 24 Feb 2021
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 ...
Posted by Michael Wonder on 18 Feb 2021
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. ...
Posted by Michael Wonder on 17 Feb 2021
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 ...
Posted by Michael Wonder on 16 Feb 2021
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 ...
Posted by Michael Wonder on 11 Feb 2021
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’. ...
Posted by Michael Wonder on 09 Feb 2021
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 ...
Posted by Michael Wonder on 03 Feb 2021
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 ...
Posted by Michael Wonder on 02 Feb 2021
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 ...
Posted by Michael Wonder on 01 Feb 2021
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 ...
Posted by Michael Wonder on 31 Jan 2021
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. ...