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RSS FeedPosted 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
EMA publishes agenda for 13-16 October 2025 CHMP meeting
13 October 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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
MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
10 October 2025 - Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them ...
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 10 Oct 2025
FDA approves expanded indication for Uzedy (risperidone) extended release injectable suspension as a treatment for adults living with bipolar I disorder
10 October 2025 - Teva Pharmaceuticals announced today that the US FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable ...
Posted by Michael Wonder on 10 Oct 2025
AstraZeneca announces historic agreement with US Government to lower the cost of medicines for American patients
10 October 2025 - AstraZeneca today announces a historic agreement with President Donald J. Trump’s administration to lower the cost ...
Posted by Michael Wonder on 10 Oct 2025
Cidara Therapeutics receives US FDA breakthrough therapy designation for CD388 in seasonal influenza prevention
9 October 2025 - Cidara Therapeutics today announced that the US FDA has granted breakthrough therapy designation for CD388 for prevention ...
Posted by Michael Wonder on 10 Oct 2025
Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma
9 October 2025 - Adcendo ApS today announced that the US FDA has granted fast track designation to ADCE-D01 for ...
Posted by Michael Wonder on 10 Oct 2025
Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept)
9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the ...