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RSS FeedPosted by Michael Wonder on 16 Jun 2021
FDA approves avapritinib for advanced systemic mastocytosis
16 June 2021 - On June 16, 2021, the FDA approved avapritinib (Ayvakit, Blueprint Medicines) for adult patients with advanced ...
Posted by Michael Wonder on 16 Jun 2021
Novartis prostate cancer drug receives U.S. FDA breakthrough designation
17 June 2021 - Swiss drugmaker Novartis has received breakthrough therapy designation from the U.S. FDA for an experimental treatment ...
Posted 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 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
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
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
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 ...
Posted by Michael Wonder on 14 Jun 2021
Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency
11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...
Posted by Michael Wonder on 13 Jun 2021
Unaffordable treatment for severe malaria highlights U.S. drug market pitfalls
11 June 2021 - When Eli Lilly announced in 2017 that it would stop producing quinidine, it was the only ...