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RSS FeedPosted by Michael Wonder on 24 Feb 2022
FDA grants BI 1015550 breakthrough therapy designation for idiopathic pulmonary fibrosis
24 February 2022 - Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022. ...
Posted by Michael Wonder on 24 Feb 2022
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
24 February 2022 - FDA sets updated PDUFA goal date of 16 June 2022. ...
Posted by Michael Wonder on 24 Feb 2022
FDA approves treatment for wider range of patients with heart failure
24 February 2022 - Today, the U.S. FDA approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization ...
Posted by Michael Wonder on 23 Feb 2022
FDA approves nalmefene hydrochloride 2 mg/2 mL injection for the treatment of known or suspected opioid overdose with natural or synthetic opioids
23 February 2022 - Purdue Pharma announced today that FDA has approved its abbreviated new drug application for nalmefene hydrochloride 2 ...
Posted by Michael Wonder on 23 Feb 2022
FDA permits marketing of first condom specifically indicated for anal intercourse
23 February 2022 - Other FDA cleared condoms can continue to be used for contraception and to prevent sexually transmitted infections. ...
Posted by Michael Wonder on 23 Feb 2022
Theragnostics announces US FDA approval for its radiodiagnostic imaging drug NephroScan (kit for the preparation of Technetium Tc 99m succimer injection)
23 February 2022 - NephroScan is now U.S. FDA approved for the preparation of Tc-99m DMSA. ...
Posted by Michael Wonder on 23 Feb 2022
Medtronic receives FDA approval for InterStim X system, the next generation of the most personalised sacral nerve stimulation therapy for bladder and bowel control
22 December 2022 - New InterStim X system provides 10 to 15 years of battery life without the need to recharge. ...
Posted by Michael Wonder on 23 Feb 2022
Provention Bio announces biologics license application resubmission for teplizumab to address complete response letter
22 February 2022 - Provention Bio today announced it has resubmitted the biologics license application for teplizumab for the delay ...
Posted by Michael Wonder on 22 Feb 2022
NeuroSigma receives FDA breakthrough device designation for Monarch eTNS system
22 February 2022 - Monarch eTNS recognised as novel device for drug resistant epilepsy. ...
Posted by Michael Wonder on 22 Feb 2022
BeiGene announces U.S. FDA acceptance of supplemental new drug application for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia
22 February 2022 - The Prescription Drug User Fee Act target action date is 22 October 2022. ...
Posted by Michael Wonder on 22 Feb 2022
Mallinckrodt provides a regulatory update on terlipressin
22 February 2022 - Mallinckrodt today announced that the U.S. FDA has issued a complete response letter regarding the Company's ...
Posted by Michael Wonder on 22 Feb 2022
AbbVie submits supplemental new drug application to U.S. FDA for cariprazine (Vraylar) for the adjunctive treatment of major depressive disorder
22 February 2022 - Submission is based on clinical trial results that include findings showing clinically and statistically significant improvement in ...
Posted by Michael Wonder on 22 Feb 2022
The truth about patient access and FDA fast tracking
21 February 2022 - University of Illinois Chicago researchers studied 135 products that received U.S. FDA approval through orphan drug and ...
Posted by Michael Wonder on 21 Feb 2022
Apple iPhone game changing new health feature cleared by FDA, coming in weeks
20 February 2022 - A new app is coming this spring which will be game changing for diabetes care. ...
Posted by Michael Wonder on 21 Feb 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for Keytruda (pembrolizumab) to identify patients with microsatellite instability-high solid tumours
21 February 2022 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA approved companion diagnostic ...