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RSS FeedPosted by Michael Wonder on 28 May 2021
Verrica Pharmaceuticals announces extension of FDA review period of its NDA for VP-102 for the treatment of molluscum contagiosum
28 May 2021 - Prescription Drug User Fee Act goal date extended by three months to 23 September 2021. ...
Posted by Michael Wonder on 28 May 2021
U.S. Food and Drug Administration approves Bristol Myers Squibb’s Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis
27 May 2021 - Bristol Myers Squibb is committed to making Zeposia accessible to appropriate patients who need it through the ...
Posted by Michael Wonder on 28 May 2021
Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes
25 May 2021 - Novartis today announced that the US FDA has granted fast track designation for sabatolimab (MBG453) for the ...
Posted by Michael Wonder on 27 May 2021
FDA approves Biohaven's Nurtec ODT (rimegepant) for prevention: now the first and only migraine medication for both acute and preventive treatment
27 May 2021 - Nurtec ODT 75 mg is the first oral CGRP antagonist approved to prevent migraine. ...
Posted by Michael Wonder on 27 May 2021
FDA grants Micro Interventional Devices breakthrough device designation for the MIA-T percutaneous tricuspid annuloplasty system
27 May 2021 - Micro Interventional Devices has received breakthrough device designation from the U.S. FDA for its MIA-T percutaneous ...
Posted by Michael Wonder on 27 May 2021
Lantheus receives U.S. FDA approval of Pylarify (piflufolastat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer
27 May 2021 - Pylarify will be available immediately to imaging centres in parts of the mid-Atlantic and southern regions and ...
Posted by Michael Wonder on 27 May 2021
Foresee Pharmaceuticals announces FDA approval of Camcevi for the treatment of advanced prostate cancer; Accord BioPharma to head the U.S. commercialisation
26 May 2021 - Foresee Pharmaceuticals announced today that the U.S. FDA has approved the new drug application for Camcevi 42 ...
Posted by Michael Wonder on 27 May 2021
U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma
26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 27 May 2021
FDA authorises additional monoclonal antibody for treatment of COVID-19
26 May 2021 - Today, the U.S. FDA issued an emergency use authorisation for the investigational monoclonal antibody therapy sotrovimab for ...
Posted by Michael Wonder on 27 May 2021
Mezzion's new drug application for its orphan drug udenafil for the treatment of single ventricle heart disease has been accepted for filing by the FDA
25 May 2021 - Mezzion Pharma is pleased to announce today that it has received notice from the FDA that ...
Posted by Michael Wonder on 26 May 2021
Influencers say they were urged to criticise Pfizer vaccine
26 May 2021 - A disinformation effort to reduce public confidence in COVID-19 vaccines tried to enrol social media commentators in ...
Posted by Michael Wonder on 26 May 2021
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...
Posted by Michael Wonder on 26 May 2021
Woebot Health receives FDA breakthrough device designation for post partum depression treatment
26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
Posted by Michael Wonder on 26 May 2021
Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once daily treatment for heavy menstrual bleeding associated with uterine fibroids
26 May 2021 - Myovant and Pfizer will jointly commercialise Myfembree with product availability expected in June. ...