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RSS FeedPosted by Michael Wonder on 11 May 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce FDA approval of Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease
10 May 2023 - PEGylated enzyme replacement therapy designed to provide long half-life. ...
Posted by Michael Wonder on 10 May 2023
Acrivon Therapeutics announces FDA grants fast track designation for development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer
9 May 2023 - In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy ...
Posted by Michael Wonder on 09 May 2023
FDA accepts application for Genentech’s Vabysmo for the treatment of retinal vein occlusion
9 May 2023 - Acceptance based on two Phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting ...
Posted by Michael Wonder on 09 May 2023
Eyenovia announces FDA approval of Mydcombi, the first ophthalmic spray for mydriasis, which also leverages the company’s proprietary Optejet device platform
8 May 2023 - Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis. ...
Posted by Michael Wonder on 09 May 2023
Vedanta Biosciences receives fast track designation for VE303
8 May 2023 - VE303 receives fast track designation for prevention of recurrent C. difficile infection ahead of global pivotal Phase ...
Posted by Michael Wonder on 09 May 2023
Farxiga extended in the US to reduce risk of cardiovascular death and hospitalisation for heart failure to a broader range of patients
8 May 2023 - FDA approval means patients with heart failure can benefit from Farxiga regardless of left ventricular ejection ...
Posted by Michael Wonder on 06 May 2023
Glaukos announces FDA acceptance of NDA submission for iDose TR
5 May 2023 - PDUFA date set for 22 December 2023. ...
Posted by Michael Wonder on 04 May 2023
Humacyte’s human acellular vessel receives FDA’s regenerative medicine advanced therapy designation for urgent arterial repair following vascular trauma
4 May 2023 - HAV granted second RMAT designation by the FDA. ...
Posted by Michael Wonder on 04 May 2023
Federal funding for discovery and development of costly HIV drugs was far more than previously estimated
1 May 2023 - In July 2012, tenofovir disoproxil fumarate-emtricitabine (Truvada) was approved by the FDA to prevent HIV infection. ...
Posted by Michael Wonder on 03 May 2023
Vertex announces US FDA approval for Kalydeco (ivacaftor) to treat eligible infants with CF ages 1 month and older
3 May 2023 - First and only CFTR modulator approved for this age group. ...
Posted by Michael Wonder on 03 May 2023
FDA approves first respiratory syncytial virus vaccine
3 May 2023 - Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine ...
Posted by Michael Wonder on 03 May 2023
Memo Therapeutics receives FDA fast track designation for AntiBKV as treatment of BKV infection in renal transplant patients
2 May 2023 - Memo Therapeutics announced today that the US FDA has granted fast track designation to AntiBKV, MTx’s ...
Posted by Michael Wonder on 03 May 2023
Tenaya Therapeutics receives FDA fast track designation for TN-201
2 May 2023 - TN-201 being developed for the potential treatment of MYBPC3-associated HCM. ...
Posted by Michael Wonder on 03 May 2023
US FDA grants breakthrough therapy designation for spesolimab for the prevention of flares in adults with generalised pustular psoriasis
2 May 2023 - Breakthrough therapy designation is supported by results from the Effisayil 2 trial which studied spesolimab in the ...
Posted by Michael Wonder on 02 May 2023
Avadel Pharmaceuticals announces final FDA approval of Lumryz (sodium oxybate) for extended-release oral suspension as the first and only once-at-bedtime oxybate for cataplexy or excessive daytime sleepiness in adults with narcolepsy
1 May 2023 - Final approval supported by robust efficacy and safety data from pivotal Phase 3 REST-ON clinical trial. ...