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RSS FeedPosted by Michael Wonder on 12 Oct 2023
Alvotech provides update on status of US biologics license application for AVT04
12 October 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 11 Oct 2023
FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
11 October 2023 - Today, the FDA approved encorafenib (Braftovi, Array BioPharma, a wholly owned subsidiary of Pfizer) with binimetinib ...
Posted by Michael Wonder on 09 Oct 2023
Alnylam announces receipt of complete response letter from US FDA for supplemental new drug application for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis
9 October 2023 - FDA cites insufficient evidence of clinical meaningfulness. ...
Posted by Michael Wonder on 08 Oct 2023
Biocon biologics receives complete response letter from US FDA for biosimilar insulin aspart
7 October 2023 - The US FDA has issued a complete response letter for the biologics license application for insulin aspart. ...
Posted by Michael Wonder on 08 Oct 2023
FDA approves Novartis Cosentyx as first intravenous formulation interleukin-17A antagonist for rheumatic diseases
6 October 2023 - First new intravenous treatment option in six years for adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic ...
Posted by Michael Wonder on 07 Oct 2023
FDA approves Arcutis’ Zoryve (roflumilast) 0.3% cream for treatment of psoriasis in children ages 6 to 11
6 October 2023 - Expanded indication for Zoryve provides new, steroid free topical for children 6 to 11 with plaque ...
Posted by Michael Wonder on 07 Oct 2023
EntroGen receives FDA approval for CRCdx RAS mutation detection kit as companion diagnostic for Vectibix
3 October 2023 - The US FDA has granted approval for EntroGen's CRCdx RAS Mutation Detection Kit as a companion diagnostic ...
Posted by Michael Wonder on 04 Oct 2023
Galderma announces progress with relabotulinumtoxinA regulatory submissions
2 October 2023 - Galderma receives FDA complete response letter with comments isolated to Chemistry, Manufacturing, and Controls items. ...
Posted by Michael Wonder on 03 Oct 2023
FDA approves Rivfloza for children ≥9 years old and adults living with primary hyperoxaluria type 1, a rare genetic condition
2 October 2023 - Novo Nordisk announced today that the US FDA has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, ...
Posted by Michael Wonder on 03 Oct 2023
US FDA grants approval for Technegas
2 October 2023 - Strong pre-existing demand expected to drive sales momentum for an immediate US wide rollout. ...
Posted by Michael Wonder on 03 Oct 2023
Takeda provides update on Exkivity (mobocertinib)
3 October 2023 - Takeda today announced that, following discussions with the US FDA, it will be working with the FDA ...
Posted by Michael Wonder on 02 Oct 2023
US FDA issues complete response letter for lebrikizumab based on inspection findings at third party manufacturer
2 October 2023 - In the letter, the FDA stated no concerns about the clinical data package, safety or label ...
Posted by Michael Wonder on 02 Oct 2023
Apellis announces US FDA approval of the Empaveli injector, a device to streamline self administration
2 October 2023 - Apellis Pharmaceuticals today announced that the US FDA has approved the Empaveli Injector. ...
Posted by Michael Wonder on 01 Oct 2023
FDA approves Biogen’s Tofidence (tocilizumab-bavi), a biosimilar referencing Actemra
29 September 2023 - Tofidence (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the US. ...
Posted by Michael Wonder on 30 Sep 2023
FDA grants first marketing authorisation for a DNA test to assess predisposition for dozens of cancer types
29 September 2023 - Today, the US FDA grantedde novo marketing authorisation for the Invitae Common Hereditary Cancers Panel, ...