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RSS FeedPosted by Michael Wonder on 16 Jun 2021
United Therapeutics announces FDA acceptance of Tyvaso DPI new drug application for priority review
16 June 2021 - FDA action expected in October 2021. ...
Posted by Michael Wonder on 16 Jun 2021
Braeburn resubmits new drug application for Brixadi (buprenorphine) extended release subcutaneous injection for moderate to severe opioid use disorder
15 June 2021 - Braeburn announces that today the new drug application for Brixadi (buprenorphine) extended release injection for subcutaneous ...
Posted by Michael Wonder on 16 Jun 2021
Emmaus Life Sciences announces submission of marketing authorisation application to Swissmedic; Ideogen to manage early access program
15 June 2021 - Emmaus Life Sciences anounced today it has received confirmation from the Swiss Agency for Therapeutic Products ...
Posted by Michael Wonder on 15 Jun 2021
6 ways the FDA’s approval of Aduhelm does more harm than good
15 June 2021 - Like many people, I was shocked when the FDA ignored the advice of its neurological drugs ...
Posted by Michael Wonder on 15 Jun 2021
FDA approves StrataGraft for the treatment of adults with thermal burns
15 June 2021 - Today, the U.S. FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact ...
Posted by Michael Wonder on 15 Jun 2021
Hugel America announces U.S. FDA acceptance of biologics license application for letibotulinumtoxinA for injection to treat glabellar (frown) lines
15 June 2021 - Prescription Drug User Fee Act target action date of 31 March 2022. ...
Posted by Michael Wonder on 15 Jun 2021
Eton Pharmaceuticals announces FDA approval of Rezipres (ephedrine hydrochloride injection)
15 June 2021 - Eton Pharmaceuticals today announced that the U.S. FDA has approved Rezipres (ephedrine hydrochloride injection) for the treatment ...
Posted by Michael Wonder on 15 Jun 2021
Cerevel Therapeutics announces fast track designation granted by the US FDA to CVL-871 for the treatment of dementia related apathy
15 June 2021 - Cerevel Therapeutics announced that the US FDA has granted fast track designation to CVL-871, a D1/D5 ...
Posted by Michael Wonder on 15 Jun 2021
Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada
14 June 2021 - Submission supported by data from the CENTAUR trial. ...
Posted by Michael Wonder on 15 Jun 2021
Medtronic announces FDA approval of its next generation recharge-free spinal cord stimulation platform
10 June 2021 - Vanta implantable neurostimulator offers up to 11 year battery life and personalised pain relief. ...
Posted by Michael Wonder on 15 Jun 2021
Moderna seeks vaccine approval for adolescents
11 June 2021 - US-based biotech company Moderna is applying for the use of its COVID-19 vaccine for adolescents aged 12 ...
Posted by Michael Wonder on 15 Jun 2021
Istari Oncology announces FDA granted fast track designation to PVSRIPO for the treatment of advanced melanoma
14 June 2021 - Istari Oncology announced today the U.S. FDA has granted fast track designation to PVSRIPO for the ...
Posted by Michael Wonder on 15 Jun 2021
Avenue Therapeutics receives complete response letter from the FDA for intravenous tramadol
14 June 2021 - Avenue Therapeutics today announced that it has received a second complete response letter from the U.S. ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...
Posted by Michael Wonder on 14 Jun 2021
The FDA still lacks a permanent chief, despite pressing, weighty problems
12 June 2021 - With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing ...