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RSS FeedPosted by Michael Wonder on 16 May 2023
U.S. Food and Drug Administration issues complete response letter for Byondis' trastuzumab duocarmazine
15 May 2023 - Complete response letter outlines FDA's request for additional information. ...
Posted by Michael Wonder on 16 May 2023
The decline of science at the FDA has become unmanageable
15 May 2023 - Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings ...
Posted by Michael Wonder on 16 May 2023
FDA grants SiSaf’s innovative siRNA therapy SIS-101-ADO orphan drug designation and rare paediatric disease designation for the treatment of autosomal dominant osteopetrosis
15 May 2023 - SiSaf announces that SIS-101-ADO, its siRNA therapeutic, has been granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 16 May 2023
Innovent receives NMPA breakthrough designation for IBI351 (KRASG12C inhibitor) as monotherapy for previously treated advanced colorectal carcinoma
15 May 2023 - Innovent Biologics announced that the Center for Drug Evaluation of China’s National Medical Products Administration has granted ...
Posted by Michael Wonder on 15 May 2023
ImmPACT Bio granted FDA fast track designation for IMPT-314 in patients with relapsed or refractory aggressive B-cell lymphoma
15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...
Posted by Michael Wonder on 15 May 2023
Caldolor now FDA approved for treatment of fever & pain in infants
15 May 2023 - Caldolor is the only injectable non-opioid approved for treating pain in infants. ...
Posted by Michael Wonder on 15 May 2023
Drug companies are minting billions on unproven treatments with FDA shortcut
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
Posted by Michael Wonder on 12 May 2023
FDA approves novel drug to treat moderate to severe hot flashes caused by menopause
12 May 2023 - Today, the US FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe ...
Posted by Michael Wonder on 11 May 2023
Otsuka and Lundbeck announce US FDA approval of supplemental new drug application for Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease
10 May 2023 - Rexulti is the first and only pharmacological treatment approved in the US for agitation associated with ...
Posted 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 ...