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RSS FeedPosted by Michael Wonder on 04 May 2024
Wegovy (semaglutide injection) available in Canada
2 May 2024 - First and only Health Canada approved once weekly medication for chronic weight management ...
Posted by Michael Wonder on 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to ...
Posted by Michael Wonder on 02 May 2024
US FDA approves high concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira
1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...
Posted by Michael Wonder on 02 May 2024
Neurocrine Biosciences announces US FDA approval of Ingrezza Sprinkle (valbenazine) capsules
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
Posted by Michael Wonder on 01 May 2024
Aquestive Therapeutics receives US FDA approval and market access for Libervant (diazepam) buccal film in paediatric patients ages 2 to 5
29 April 2024 - Announces immediate availability of Libervant 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg for ...
Posted by Michael Wonder on 30 Apr 2024
Johnson & Johnson receives positive CHMP opinion recommending full approval for Sirturo (bedaquiline) for treatment of multidrug-resistant tuberculosis
29 April 2024 - Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves first drug for WHIM syndrome, a rare disorder that can lead to recurrent, life threatening infections
29 April 2024 - The US FDA has approved Xolremdi (mavorixafor) capsules in patients 12 years of age and older with ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
29 April 2024 - Today, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen) for recurrent or metastatic cervical ...
Posted by Michael Wonder on 27 Apr 2024
Highlights from the 22-25 April 2024 CHMP meeting
26 April 2024 - The EMA’s CHMP recommended eight medicines for approval at its April 2024 meeting. ...
Posted by Michael Wonder on 27 Apr 2024
Biogen receives positive CHMP opinion for Tofidence (tocilizumab), a biosimilar referencing RoActemra
25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...
Posted by Michael Wonder on 27 Apr 2024
Pierre Fabre Laboratories receive positive CHMP opinion for Obgemsa (vibegron) in overactive bladder syndrome
26 April 2024 - Pierre Fabre Laboratories announced that the CHMP of the EMA has adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 27 Apr 2024
Takeda receives positive CHMP opinion for fruquintinib in previously treated metastatic colorectal cancer
26 April 2024 - If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal ...
Posted by Michael Wonder on 27 Apr 2024
Johnson & Johnson receives positive CHMP opinion for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
26 April 2024 - The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy ...
Posted by Michael Wonder on 27 Apr 2024
CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
26 April 2024 - Recommendation based on results from CheckMate-901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate ...
Posted by Michael Wonder on 26 Apr 2024
Vertex announces European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...