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RSS FeedPosted by Michael Wonder on 19 Dec 2025
Cytokinetics announces FDA approval of Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms
19 December 2025 - FDA Approval based on results of SEQUOIA-HCM. ...
Posted by Michael Wonder on 19 Dec 2025
Egetis Therapeutics initiates new drug application in the USA for Emcitate (tiratricol) for MCT8 deficiency
19 December 2025 - Egetis Therapeutics today announced that the Company has initiated a rolling new drug application submission to ...
Posted by Michael Wonder on 19 Dec 2025
Sangamo Therapeutics initiates rolling submission of BLA to US FDA for ST-920 in Fabry disease
18 December 2025 - Sangamo expects to complete biological license application submission under accelerated approval pathway in second quarter of ...
Posted by Michael Wonder on 19 Dec 2025
BeOne Medicines granted US FDA fast track designation for BGB-B2033 as treatment for hepatocellular carcinoma
18 December 2025 - BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver ...
Posted by Michael Wonder on 18 Dec 2025
Novo Nordisk files for FDA approval of CagriSema, the first onceweekly combination of GLP‑1 and amylin analogues for weight management
18 December 2025 - – Today, Novo Nordisk announced the submission of a new drug application to the US FDA ...
Posted by Michael Wonder on 18 Dec 2025
FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
17 December 2025 - Today, the FDA approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech) for subcutaneous injection for adult ...
Posted by Michael Wonder on 17 Dec 2025
FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
17 December 2025 - Today, the FDA approved rucaparib (Rubraca, pharmaand) for adults with a deleterious BRCA mutation (germline and/or ...
Posted by Michael Wonder on 17 Dec 2025
Vanda announces submission of biologics license application to the FDA for imsidolimab for the treatment of generalised pustular psoriasis
15 December 2025 - Vanda Pharmaceuticals today announced the submission of a biologics license application to the US FDA) for ...
Posted by Michael Wonder on 17 Dec 2025
Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma
16 December 2025 - Approval based on SWIFT trials showing significantly lower rate of annualised asthma exacerbations in patients receiving depemokimab ...
Posted by Michael Wonder on 17 Dec 2025
FDA eliminates major barrier to using real world evidence in drug and device application reviews
15 December 2025 - The US FDA today removed a key limitation on the use of real world evidence used in ...
Posted by Michael Wonder on 16 Dec 2025
Palvella Therapeutics granted FDA fast track designation for Qtorin 3.9% rapamycin anhydrous gel for the treatment of angiokeratomas
16 December 2025 - Angiokeratomas are characterised by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of ...
Posted by Michael Wonder on 16 Dec 2025
Adagene announces FDA fast track designation for muzastotug (ADG126)
16 December 2025 - Adagene today announced that the US FDA has designated muzastotug, in combination with Merck’s anti-PD-1 therapy, Keytruda ...
Posted by Michael Wonder on 16 Dec 2025
Aldeyra Therapeutics announces PDUFA extension of the new drug application of reproxalap for the treatment of dry eye disease
15 December 2025 - Aldeyra Therapeutics today announced that the US FDA has extended the PDUFA target action date for the ...
Posted by Michael Wonder on 16 Dec 2025
Historic first in women's sexual health: FDA grants approval for Addyi (flibanserin) in post-menopausal women
15 December 2025 - Sprout Pharmaceuticals today announced a monumental milestone for women's health: the US FDA has approved Addyi ...
Posted by Michael Wonder on 16 Dec 2025
Tecvayli and Darzalex Faspro combination selected for Commissioner’s National Priority Voucher Pilot program
15 December 2025 - We are pleased the US FDA has selected the teclistamab MajesTEC-3 supplemental biologics license application to participate ...