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RSS FeedPosted by Michael Wonder on 08 Mar 2024
FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight
8 March 2024 - Today, the US FDA approved a new indication for use for Wegovy (semaglutide) injection to reduce the ...
Posted by Michael Wonder on 08 Mar 2024
MindMed receives FDA breakthrough therapy designation for MM120 for generalized anxiety disorder
7 March 2024 - Mind Medicine today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for ...
Posted by Michael Wonder on 07 Mar 2024
FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
7 March 2024 - Today, the FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) with obinutuzumab for relapsed or refractory ...
Posted by Michael Wonder on 07 Mar 2024
FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma
7 March 2024 - On 6 March 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with cisplatin and gemcitabine ...
Posted by Michael Wonder on 06 Mar 2024
Trellis Bioscience's TRL1068 receives FDA fast track and QIDP designations, amplifying commitment to combat infectious diseases
6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...
Posted by Michael Wonder on 06 Mar 2024
FDA approves inotuzumab ozogamicin for paediatric patients with acute lymphoblastic leukaemia
6 March 2024 - Today, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for paediatric patients 1 year and older with ...
Posted by Michael Wonder on 06 Mar 2024
Vanda Pharmaceuticals announces FDA update for supplemental NDA for Hetlioz in the treatment of insomnia
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...
Posted by Michael Wonder on 06 Mar 2024
Camurus announces FDA acceptance of NDA submission for Oclaiz for treatment of acromegaly
5 March 2024 - PDUFA set to 21 October 2024. ...
Posted by Michael Wonder on 05 Mar 2024
Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate 0.05% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery
4 March 2024 - Formosa Pharmaceuticals and AimMax Therapeutics announced today that the US FDA has approved clobetasol propionate 0.05% ...
Posted by Michael Wonder on 05 Mar 2024
Ellipses' next generation selective RET inhibitor EP0031/A400 granted fast track designation by US FDA
5 March 2024 - Ellipses Pharma announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 05 Mar 2024
Sandoz receives FDA approval for first and only denosumab biosimilars
5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...
Posted by Michael Wonder on 05 Mar 2024
Zevra Therapeutics provides FDA update on the PDUFA action date for arimoclomol as a treatment for Niemann-Pick disease type C
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
Posted by Michael Wonder on 04 Mar 2024
SpringWorks Therapeutics initiates rolling submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
4 March 2024 - SpringWorks Therapeutics announced today that the Company has initiated a rolling submission of a new drug application ...
Posted by Michael Wonder on 04 Mar 2024
Hugel receives US FDA approval for its botulinum toxin Letybo
3 March 2024 - Hugel becomes the first and only Korean company that have market approvals in all three major aesthetic ...
Posted by Michael Wonder on 01 Mar 2024
FDA approves amivantamab-vmjw for EGFR exon 20 insertion mutated non-small cell lung cancer indications
1 March 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for the first-line treatment of ...