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RSS FeedPosted by Michael Wonder on 11 Jun 2021
Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis
11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 10 Jun 2021
Adamis provides update on Zimhi
9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...
Posted by Michael Wonder on 08 Jun 2021
Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease
8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...
Posted by Michael Wonder on 31 May 2021
State slower to ‘adopt new drugs’ than most of western Europe
31 May 2021 - Medicines regularly not worth approving at asking price. ...
Posted by Michael Wonder on 28 May 2021
Verrica Pharmaceuticals announces extension of FDA review period of its NDA for VP-102 for the treatment of molluscum contagiosum
28 May 2021 - Prescription Drug User Fee Act goal date extended by three months to 23 September 2021. ...
Posted by Michael Wonder on 20 May 2021
Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA
20 May 2021 - PDUFA date is 17 October 2021. ...
Posted by Michael Wonder on 18 May 2021
CMS delays Medicare payments for breakthrough devices until December
17 May 2021 - Medicare coverage for FDA designated breakthrough medical devices will have to wait several more months, despite ...
Posted by Michael Wonder on 13 May 2021
Long waits for life saving drugs harming Canadians: report
13 May 2021 - Canadians wait 15 months longer on average for new and potentially life-saving medications compared to Americans ...
Posted by Michael Wonder on 19 Apr 2021
A 12-week sprint’: PM flags plan to vaccinate under-50s in lead-up to Christmas
19 April 2021 - More than 6 million Australians could be vaccinated in the last 12 weeks of the year ...
Posted by Michael Wonder on 15 Apr 2021
Australian population unlikely to be vaccinated until end of next year
15 April 2021 - Leading public health experts have warned the Australian population is unlikely to get COVID-19 vaccinations until ...
Posted by Michael Wonder on 14 Apr 2021
New blow to rollout as Novavax Covid-19 vaccine hits supply hiccup
15 April 2021 - Australia’s vaccine rollout has been dealt another blow as Novavax confirms manufacturing supply shortages mean it ...
Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...
Posted by Michael Wonder on 11 Apr 2021
Scott Morrison abandons target to have all Australians vaccinated against COVID-19 by the end of the year
11 April 2021 - The Prime Minister has abandoned all targets for the nationwide rollout of COVID-19 vaccines after new medical ...
Posted by Michael Wonder on 09 Apr 2021
Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. ...
Posted by Michael Wonder on 08 Apr 2021
October vaccine target all but over after AstraZeneca blood clot concerns prompt rollout shakeup
8 April 2021 - Hopes of all Australians having at least their first COVID-19 vaccine by October look all but ...