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RSS FeedPosted by Michael Wonder on 30 Apr 2023
Teva and MedinCell announce FDA approval of Uzedy (risperidone) extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, for the treatment of schizophrenia in adults
28 April 2023 - In a Phase 3 clinical trial, Uzedy demonstrated up to 80% reduction in risk of schizophrenia relapse ...
Posted by Michael Wonder on 28 Apr 2023
FDA approves Otsuka and Lundbeck’s Abilify Asimtufii (aripiprazole), the first once every two months long-acting injectable for the treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults
27 April 2023 - Otsuka and Lundbeck announce the US FDA has approved the new drug application for Abilify Asimtufii (aripiprazole) ...
Posted by Michael Wonder on 28 Apr 2023
US FDA approves Prevnar 20, Pfizer’s 20 valent pneumococcal conjugate vaccine for infants and children
27 April 2023 - Prevnar 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect ...
Posted by Michael Wonder on 27 Apr 2023
Seres Therapeutics and Nestlé Health Science announce FDA approval of Vowst (fecal microbiota spores, live-brpk) for prevention of recurrence of C. difficile infection in adults following antibacterial treatment for recurrent CDI
26 April 2023 - First and only FDA approved orally administered microbiota-based therapeutic, validating Seres’ microbiome platform. ...
Posted by Michael Wonder on 26 Apr 2023
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 2 through 5 with certain mutations
26 April 2023 - About 900 children with cystic fibrosis will now have a medicine to treat the underlying cause of ...
Posted by Michael Wonder on 25 Apr 2023
FDA grants accelerated approval for Qalsody (tofersen) for SOD1-ALS, a major scientific advancement as the first treatment to target a genetic cause of ALS
25 April 2023 - FDA granted accelerated approval of Qalsody based on a reduction of neurofilament, a marker of neurodegeneration. ...
Posted by Michael Wonder on 19 Apr 2023
FDA approves Genentech's Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma
19 April 2023 - Polarix trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% ...
Posted by Michael Wonder on 18 Apr 2023
CSL Behring receives FDA approval for Hizentra (immune globulin subcutaneous [human] 20% liquid) 50 mL pre-filled syringe
18 April 2023 - Hizentra is the first and only immune globulin available in pre-filled syringes, offering those living with ...
Posted by Michael Wonder on 18 Apr 2023
Hugel hit with another complete response letter from the FDA
18 April 2023 - Hugel's much anticipated US launch of its botulinum toxin product, Letybo, has experienced yet another setback. ...
Posted by Michael Wonder on 18 Apr 2023
US FDA approves Qulipta (atogepant) for adults with chronic migraine
17 April 2023 - Qulipta now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including ...
Posted by Michael Wonder on 17 Apr 2023
IntelGenx announces FDA approval of Rizafilm for the treatment of acute migraine
17 April 2023 - Partner Gensco Pharma preparing to commercially launch Rizafilm across the United States as soon as is practicable. ...
Posted by Michael Wonder on 17 Apr 2023
FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation
17 April 2023 - Today, the US FDA approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy to quicken ...
Posted by Michael Wonder on 16 Apr 2023
Horizon Therapeutics announces FDA approval of an update to the indication language for Tepezza (teprotumumab-trbw) to specify its use in thyroid eye disease patients regardless of disease activity or duration
14 April 2023 - Updated indication language reinforces the importance of unrestricted access for patients across full spectrum of thyroid ...
Posted by Michael Wonder on 14 Apr 2023
Alvotech provides regulatory update on AVT02 biologics license application
13 April 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license ...
Posted by Michael Wonder on 13 Apr 2023
U.S. FDA issues complete response letter for mirikizumab
13 April 2023 - Eli Lilly announced the US FDA has issued a complete response letter for the mirikizumab biologic license ...