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RSS FeedPosted 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, ...
Posted by Michael Wonder on 29 Sep 2023
Fabre-Kramer Pharmaceuticals announces FDA approval of Exxua, the first and only oral selective 5HT1a receptor agonist for the treatment of major depressive disorder in adults
28 September 2023 - Exxua is the first new chemical entity utilising this single mechanism approved for the treatment of major ...
Posted by Michael Wonder on 29 Sep 2023
Appili Therapeutics announces US FDA approval of Likmez (ATI-1501) metronidazole oral suspension
25 September 2023 - Currently Likmez is the only liquid oral suspension of metronidazole approved in the US. ...
Posted by Michael Wonder on 28 Sep 2023
Amicus Therapeutics announces FDA approval and launch of new treatment for Pompe disease
28 September 2023 - Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) approved in ERT experienced adults. ...