Blog
RSS FeedPosted 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 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 26 Apr 2024
US FDA approves Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with hemophilia B
26 April 2024 - Pfizer announced today that the US FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults ...
Posted by Michael Wonder on 25 Apr 2024
FDA approves new treatment for uncomplicated urinary tract infections
24 April 2024 - Today, the US FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
Posted by Michael Wonder on 23 Apr 2024
Abeona Therapeutics provides regulatory update on Pz-cel
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...
Posted by Michael Wonder on 22 Apr 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG unresponsive non-muscle invasive bladder cancer
22 April 2024 - Today, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult ...
Posted by Michael Wonder on 19 Apr 2024
US FDA approves subcutaneous administration of Takeda’s Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
19 April 2024 - Entyvio is now available in the US in both intravenous and subcutaneous administrations for maintenance treatment ...
Posted by Michael Wonder on 18 Apr 2024
Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
Posted by Michael Wonder on 18 Apr 2024
FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK positive early stage lung cancer
18 April 2024 - Approval based on Phase 3 ALINA study showing Alecensa reduced the risk of disease recurrence or death ...
Posted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...