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RSS FeedPosted by Michael Wonder on 24 May 2020
Federal scientists finally publish remdesivir data
23 May 2020 - A clinical trial led to the authorisation of the only drug shown to work in COVID-19 patients. ...
Posted by Michael Wonder on 24 May 2020
FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on COVID-19 vaccine project
22 May 2020 - FDA stalwart Janet Woodcock will temporarily step aside as the director of the agency’s Center for ...
Posted by Michael Wonder on 24 May 2020
Hikma receives FDA approval for its generic Vascepa
22 May 2020 - Hikma Pharmaceuticals today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received ...
Posted by Michael Wonder on 24 May 2020
Zealand Pharma announces FDA acceptance of new drug application for the dasiglucagon HypoPal rescue pen for treatment of severe hypoglycemia
22 May 2020 - PDUFA target action date scheduled for 27 March 2021. ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Takeda’s Alunbrig (brigatinib) as a first-line treatment option for patients diagnosed with rare and serious form of lung cance
22 May 2020 - Long-term results from the Phase 3 ALTA 1L trial established Alunbrig as a superior first-line treatment compared ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Evofem Biosciences' Phexxi (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal prescription gel for the prevention of pregnancy
22 May 2020 - A new class of female-controlled birth control for use in-the-moment. ...
Posted by Michael Wonder on 23 May 2020
Orphazyme’s arimoclomol receives US fast track designation in amyotrophic lateral sclerosis
22 May 2020 - Orphazyme announces that the Company has received fast track designation from the US FDA for the development ...
Posted by Michael Wonder on 22 May 2020
Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis
21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...
Posted by Michael Wonder on 22 May 2020
Sunovion announces U.S. FDA approval of Kynmobi (apomorphine hydrochloride) sublingual film for the treatment of Parkinson’s disease OFF episodes
21 May 2020 - First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes. ...
Posted by Michael Wonder on 21 May 2020
Drug innovation is back in fashion
21 May 2020 - Big pharma is no longer the villain. ...
Posted by Michael Wonder on 21 May 2020
What to expect when a coronavirus vaccine finally arrives
20 May 2020 - Sobering lessons from the history of the polio vaccine. ...
Posted by Michael Wonder on 21 May 2020
Coronavirus revives debate over drug pricing
21 May 2020 - Lure of profits laid groundwork for some COVID-19 treatments, though may not determine who finds a cure. ...
Posted by Michael Wonder on 21 May 2020
Chiesi Group receives FDA approval for Ferriprox (deferiprone) twice-a-day tablets
21 May 2020 - Chiesi Global Rare Diseases today announced that the U.S. FDA has approved Ferriprox (deferiprone) twice-a-day tablets for ...
Posted by Michael Wonder on 21 May 2020
Cipla receives final approval for generic version of Migranal (dihydroergotamine mesylate 4 mg/mL nasal spray) with a competitive generic therapy designation
21 May 2020 - Cipla today announced that it has received final approval for its abbreviated new drug application for ...