Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
Posted by Michael Wonder on 04 Mar 2021
Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
Posted by Michael Wonder on 04 Mar 2021
Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 04 Mar 2021
FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
Posted by Michael Wonder on 04 Mar 2021
FDA releases a new plan to bring its data skills up to speed
4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...
Posted by Michael Wonder on 04 Mar 2021
FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...
Posted by Michael Wonder on 04 Mar 2021
MedAlliance receives fourth FDA breakthrough device designation for sirolimus drug eluting balloon in treatment of de novo coronary lesions
4 March 2021 - MedAlliance has now been awarded breakthrough status for SELUTION SLR, its sustained limus release DEB catheter, in ...
Posted by Michael Wonder on 04 Mar 2021
U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer
3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...
Posted by Michael Wonder on 04 Mar 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
Posted by Michael Wonder on 03 Mar 2021
Strongbridge Biopharma announces submission of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. FDA
2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...
Posted by Michael Wonder on 03 Mar 2021
On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
Posted by Michael Wonder on 03 Mar 2021
Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA
3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...
Posted by Michael Wonder on 03 Mar 2021
Oyster Point Pharma announces FDA acceptance for filing new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...
Posted by Michael Wonder on 03 Mar 2021
KemPharm announces FDA approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), a new once daily treatment for ADHD
2 March 2021 - KemPharm today announced that the U.S. FDA has approved the new drug application for Azstarys (formerly referred ...
Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...