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RSS FeedPosted by Michael Wonder on 02 Jun 2022
Eagle Pharmaceuticals announces submission of new drug application to US FDA for landiolol, a beta-1 adrenergic blocker
1 June 2022 - Submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, ...
Posted by Michael Wonder on 01 Jun 2022
Apellis announces submission of new drug application to the FDA for pegcetacoplan for geographic atrophy
1 June 2022 - Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the United States ...
Posted by Michael Wonder on 31 May 2022
Y-mAbs Announces FDA acceptance of biologics license application for Omblastys (omburtamab) for the treatment of neuroblastoma for priority review
31 May 2022 - Y-mAbs Therapeutics today announced that the biologics license application for Omblasyts (omburtamab) for the treatment of paediatric ...
Posted by Michael Wonder on 31 May 2022
TG Therapeutics announces FDA extension of BLA PDUFA date for ublituximab to treat patients with RMS
31 May 2022 - New PDUFA goal date of 28 December 2022. ...
Posted by Michael Wonder on 31 May 2022
US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027 for the as needed treatment or prevention of symptoms in asthma patients
31 May 2022 - Results from Phase 3 trials conducted by Avillion in over 4,000 patients show that PT027, a novel ...
Posted by Michael Wonder on 31 May 2022
FDA accepts Dupixent (dupilumab) for priority review in adults with prurigo nodularis
31 May 2022 - Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., ...
Posted by Michael Wonder on 31 May 2022
Xbrance provides update on ranibizumab biosimilar candidate FDA filing
30 May 2022 - Xbrane Biopharma has withdrawn its biologics license application for its investigational biosimilar candidate to Lucentis after ...
Posted by Michael Wonder on 28 May 2022
U.S. FDA declines to approve Eton Pharma's anti-seizure drug
27 May 2022 - Eton Pharmaceuticals said on Friday the U.S. FDA declined to approve its anti-seizure drug lamotrigine. ...
Posted by Michael Wonder on 26 May 2022
Reata Pharmaceuticals announces FDA filing acceptance and priority review designation for the NDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia
26 May 2022 - Application assigned a PDUFA date of 30 November 2022. ...
Posted by Michael Wonder on 25 May 2022
Phathom Pharmaceuticals announces FDA acceptance for filing of vonoprazan NDA for the treatment of erosive oesophagitis
25 May 2022 - Phathom Pharmaceuticals announced today the U.S. FDA has accepted for review the company’s new drug application for ...
Posted by Michael Wonder on 24 May 2022
FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
Posted by Michael Wonder on 24 May 2022
ImmunityBio submits biologics license application for N-803 plus BCG for patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 May 2022 - Results for this FDA designated breakthrough therapy exceed historical complete response rates and duration of response ...
Posted by Michael Wonder on 24 May 2022
ImmunoGen announces acceptance of biologics license application for mirvetuximab soravtansine in ovarian cancer by US Food and Drug Administration with priority review
23 May 2022 - PDUFA date is 28 November 2022. ...
Posted by Michael Wonder on 24 May 2022
Nymox receives RTF letter from FDA
23 May 2022 - Nymox Pharmaceutical Corporation reports today that it has received a refusal to file letter from FDA ...
Posted by Michael Wonder on 23 May 2022
US FDA accepts for review Biohaven's new drug application filing of intranasal zavegepant for the acute treatment of migraine
23 May 2022 - If approved, zavegepant nasal spray would be the only FDA approved calcitonin gene related peptide receptor antagonist ...