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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Dec 2025
US FDA approves LIB Therapeutics’ Lerochol (lerodalcibep-liga) for adults with elevated LDL-cholesterol
15 December 2025 - Lerochol expected to be available in the US in spring 2026. ...
Posted by Michael Wonder on 15 Dec 2025
Sentynl Therapeutics announces FDA acceptance of CUTX-101 NDA resubmission
15 December 2025 - Sentynl Therapeutics today announced that the US FDA has accepted the resubmission of its new drug ...
Posted by Michael Wonder on 15 Dec 2025
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
15 December 2025 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) in combination with pertuzumab for the first-line ...
Posted by Michael Wonder on 15 Dec 2025
US FDA approves Daybue STIX (trofinetide) for oral solution, a new powder formulation, for Rett syndrome
15 December 2025 - Neuren Pharmaceuticals today announced that its partner Acadia Pharmaceuticals has received US FDA approval of Daybue ...
Posted by Michael Wonder on 14 Dec 2025
Milestone receives FDA approval of Cardamyst (etripamil) as first and only self-administered nasal spray for adults with paroxysmal supraventricular tachycardia
12 December 2025 - First FDA approved treatment in 30+ years for more than 2 million Americans with paroxysmal supraventricular tachycardia. ...
Posted by Michael Wonder on 13 Dec 2025
FDA approves two oral therapies to treat gonorrhea
12 February 2025 - Approvals are for uncomplicated urogenital gonorrhea. ...
Posted by Michael Wonder on 13 Dec 2025
BioCryst announces FDA approval of Orladeyo (berotralstat) oral pellets, first and only oral prophylactic treatment for patients with HAE aged 2 to <12 years
12 December 2025 - BioCryst Pharmaceuticals today announced that the US FDA has approved its new drug application for the ...
Posted by Michael Wonder on 12 Dec 2025
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
12 December 2025 - Today, the FDA approved niraparib and abiraterone acetate (Akeega, Janssen Biotech) with prednisone for adults with ...