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RSS FeedPosted 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 16 Oct 2025
Rocket Pharmaceuticals announces FDA acceptance of BLA resubmission of Kresladi for the treatment of severe leukocyte adhesion deficiency-I
14 October 2025 - PDUFA target action date is 28 March 2026. ...
Posted by Michael Wonder on 15 Oct 2025
Roche's Elecsys pTau181 becomes the only FDA cleared blood test for use in primary care to rule out Alzheimer's related amyloid pathology
13 October 2025 - Roche today announced that the US FDA has cleared its Elecsys pTau181 test, the only blood ...
Posted by Michael Wonder on 14 Oct 2025
Akamis Bio receives FDA fast track designation for NG-350A for the treatment of mismatch repair proficient locally advanced rectal cancer
14 October 2025 - NG-350A is a systemically delivered oncolytic immunotherapy driving intra-tumoral expression of a CD40 agonist monoclonal antibody. ...
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 ...
Posted by Michael Wonder on 11 Oct 2025
FDA frants RMAT designation to Avobis Bio's implantable cell therapy AVB-114 for Crohn's perianal fistulas
3 October 2025 - Avobis Bio announced today that the US FDA has granted regenerative medicine advanced therapy designation for AVB-114, ...