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MAIA Biotechnology has reported P-II (THIO-101) trial data assessing ateganosine followed by Libtayo (cemiplimab) in pts with advanced NSCLC who progressed after ≥2 SoC therapy regimens
As of Jun 30,…
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The CVMP has recommended Portela (relfovetmab) for alleviating osteoarthritis pain in cats, with an EC decision expected in Q4’25 & commercial launch planned for 2026
Opinion was based on…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:
AstraZeneca Reports P-III…
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The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome
Designation was based on P-I/II (HALOS) trial assessing ION582 in pts…
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Japan’s PMDA has accepted the NDA of nadofaragene firadenovec (intravesically; Q3W) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS ± papillary tumors (Ta/T1)
NDA was backed by…
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Tempus AI has received the US FDA 510(k) clearance for its updated Tempus Pixel, an AI-powered cardiac imaging platform, with the ability to generate T1 & T2 inline maps…
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Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in China
Additionally, Opatisumab is…
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Kashiv BioSciences has entered into a licensing & supply agreement with CRISTÁLIA for the commercialization of ADL-018, a biosimilar version of Xolair (omalizumab) in Latin America
As per the…
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The EMA has received MAA of icotrokinra (QD) for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO
MAA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2)…
Medical psychedelics are a fascinating field that modern science has yet to comprehend completely. Researchers are still digging up, trying to find evidence-based outcomes to tap into a whole new…