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RSS FeedPosted by Michael Wonder on 19 Oct 2025
Enterome receives FDA fast track designation in follicular lymphoma for lead OncoMimics immunotherapy EO2463
16 October 2025 - Enterome announces today that the US FDA has granted fast track designation for follicular lymphoma in the ...
Posted by Michael Wonder on 18 Oct 2025
FDA approves Novo Nordisk's oral semaglutide for cardiovascular risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event
17 October 2025 - In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to ...
Posted by Michael Wonder on 17 Oct 2025
Silver Creek Pharmaceuticals receives FDA fast track designation for Scp776 in acute ischaemic stroke
17 October 2025 - Silver Creek Pharmaceuticals today announced that the US FDA has granted fast track designation to scp776, its ...
Posted by Michael Wonder on 17 Oct 2025
Tezspire approved in the US for chronic rhinosinusitis with nasal polyps
17 October 2025 - AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for the add-on maintenance treatment of ...
Posted by Michael Wonder on 16 Oct 2025
NovelWise Pharmaceutical receives FDA fast track designation for NBM-BMX in metastatic uveal melanoma
14 October 2025 - NovelWise Pharmaceutical today announced that the US FDA has granted fast track designation for NBM-BMX, a ...
Posted by Michael Wonder on 16 Oct 2025
atai Life Sciences and Beckley Psytech announce US FDA breakthrough therapy designation granted to BPL-003, underscoring its potential in treatment-resistant depression
16 October 2025 - FDA designation follows previously announced Phase 2b topline data which showed rapid and durable anti-depressant outcomes following ...
Posted by Michael Wonder on 16 Oct 2025
FDA accepts Cingulate’s new drug application for CTx-1301 in attention deficit hyperactivity disorder and sets a 31 May 2026 PDUFA date
14 October 2025 - Cingulate today announced that the US FDA has accepted for review the new drug application for CTx-1301 ...
Posted by Michael Wonder on 14 Oct 2025
MannKind announces US FDA accepts for review its supplemental biologics license application for inhaled ansulin (Afrezza) in children and adolescents aged 4-17 years living with diabetes
13 October 2025 - MannKind Corporation today announced that the US FDA has accepted the supplemental biologics license application seeking approval ...
Posted by Michael Wonder on 13 Oct 2025
FDA awards fast track designation to Epion Therapeutics for its EpiSmart epithelium on cross linking system
13 October 2025 - Epion Therapeutics today announced that the US FDA granted fast track designation for EpiSmart Epithelium-On Cross-Linking System, ...
Posted by Michael Wonder on 13 Oct 2025
Bicara Therapeutics announces ficerafusp alfa granted breakthrough therapy designation by US FDA for first-line HPV negative metastatic or with unresectable, recurrent head and neck squamous cell carcinoma
13 October 2025 - Bicara Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ficerafusp alfa in ...
Posted by Michael Wonder on 13 Oct 2025
BeOne Medicines’ sonrotoclax granted breakthrough therapy designation by US FDA
13 October 2025 - Breakthrough designation based on early, positive results of a Phase 1/2 study of sonrotoclax in patients with ...
Posted by Michael Wonder on 13 Oct 2025
Denali Therapeutics announces FDA review extension of BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome)
13 October 2025 - Denali Therapeutics today announced that the US FDA has extended its review timeline of the biologics license ...
Posted by Michael Wonder on 13 Oct 2025
Blacksmith Medicines receives FDA qualified infectious disease product and fast track designation for FG-2101, a novel antibiotic targeting LpxC
13 October 2025 - Blacksmith Medicines announced today that the US FDA has granted qualified infectious disease product and the ...
Posted by Michael Wonder on 13 Oct 2025
US FDA approves updated indication statement for Rinvoq (upadacitinib) for the treatment of inflammatory bowel disease
13 October 2025 - Updated indication allows the use of Rinvoq (upadacitinib) prior to the use of tumour necrosis factor blocking ...
Posted by Michael Wonder on 11 Oct 2025
SQ Innovation announces FDA approval of Lasix ONYU for treatment of edema in heart failure
8 October 2025 - -- SQ Innovation today announced that the US FDA has approved its drug-device combination Lasix ONYU ...