Dipanshu Dixit
Shots:
The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 2 New Chemical Entites in May 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were GSk’s Blenrep to Treat R/R Multiple Myeloma
PharmaShots has compiled a list of 4 drugs that have been…
Shots:
ImmVira dosed the first pt with NMIBC in a P-II study evaluating MVR-T3011. Based on approval discussion with the US FDA the company aims to confirm the recommended P-II dose (RP2D) of intravesical administered MVR-T3011 and assess its anti-tumor efficacy in BCG-unresponsive NMIBC pts
MVR-T3011 preliminary data presented at ESMO’24 showed a high CRR…
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The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025)
The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…
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George Medicines’ Widaplik (telmisartan, amlodipine, and indapamide) has been approved by the US FDA for treating adult hypertension, including as initial therapy; launch is anticipated in Q4’25
The approval was supported by two P-III global studies showing Widaplik significantly improved blood pressure and control rates vs PBO & dual drug combinations
Widaplik (GMRx2), a…
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PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025
The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry
The major highlighted drug was AbbVie’s Emrelis securing…
Shots:
The US FDA has granted 510(k) clearance to the B3 GEL System to protect healing tissue planes and preserve mobility; launch is anticipated at the end of 2025
Preclinical studies supporting clearance showed that B3 GEL reduced tissue binding and improved range of motion, with greater flexion and extension in treated models compared to controls…
Shots:
The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapy
The application was based on Part 1 of the P-III (MANEUVER) global study, trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment, the trial also…