Mabwell Initiates P-III Trial for 9MW2821 in TNBC

Shots: Mabwell has initiated a P-III trial of 9MW2821 in triple-negative breast cancer (TNBC), marking the fourth pivotal study for 9MW2821 The trial will assess the efficacy of 9MW2821 vs the investigator’s choice chemotherapy in locally advanced or metastatic TNBC pts previously treated with taxane-based CT ± immunotherapy & a topoisomerase inhibitor-based ADC 9MW2821, a…

ByRidhi RastogiApril 24, 2026

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Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Shots: J&J has reported data from the P-III (Vivacity-MG3) trial assessing Imaavy + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), plus from an ongoing OLE trial. Also, enrolment is ongoing in the EPIC trial of Imaavy against efgartigimod The 24wk. Post-hoc analysis data showed adults receiving Imaavy…

ByRidhi RastogiApril 24, 2026

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Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

ByRidhi RastogiApril 23, 2026

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Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The Regeneron's P-III (NIMBLE) trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to either cemdisiran monotx. (600mg, SC, Q12W), pozelimab monotx. (200 mg, Q4W), cemdi-poze (200mg each, Q4W), or PBO (Q4W) cemdisiran (Q12W; n=64) vs PBO (n=59) improved gMG within 2wks., sustained to Wk. 24; MG-ADL (1EP) improved by 4.5 vs…

ByRidhi RastogiApril 22, 2026

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Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD

Shots: The Genentech's P-III (METEOROID) trial data assessed Enspryng (60, 120 or 180mg based on body weight; SC) vs PBO, administered at 0, 2 & 4wks., then Q4W thereafter in pts (≥12yrs.) with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) Trial met its 1EP with 87% vs 67% relapse-free pts at 48wks., & response onset as…

ByRidhi RastogiApril 22, 2026

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Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Shots: The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…

ByRidhi RastogiApril 22, 2026

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Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease

Shots: Monopar has highlighted P-III (FoCus) trial data assessing ALXN1840 (tiomolibdate choline, TMC; n=77) vs SoC (n=35) in Wilson disease pts with neurologic symptoms at baseline, at AAN’26 Trial showed better outcomes with ALXN1840, with lower neurologic worsening (9% vs 25%) & higher improvement (45% vs 32%) vs SoC, plus greater CGI-S (61% vs 17%)…

ByRidhi RastogiApril 21, 2026

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Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…

ByRidhi RastogiApril 21, 2026

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TJ Biopharma Licenses Felzartamab to Biogen for Greater China in ~$850M Deal

Shots: TJ Bio has granted Biogen exclusive rights to felzartamab in Greater China, giving Biogen full global ownership as the drug advances through P-III trials across multiple immune-mediated diseases As per the deal, TJ Bio will receive $100M upfront, with ~$750M in commercial & sales milestones, plus mid-single to low-double-digit % of royalties on Greater…

ByRidhi RastogiApril 21, 2026

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Eli Lilly Reports Positive P-III (ACHIEVE-4) Data of Foundayo in Type 2 Diabetes and Obesity or Overweight

Shots: Eli Lilly reported positive topline results from the P-III (ACHIEVE-4) study of Foundayo (orforglipron) vs insulin glargine in ~2,700 pts with type 2 diabetes, and obesity or overweight with elevated CV risk, meeting the 1EP of non-inferiority in MACE-4 events Foundayo demonstrated a 16% lower risk of MACE-4 and 23% lower risk of MACE-3,…

ByPrince GiriApril 17, 2026

Mabwell Initiates P-III Trial for 9MW2821 in TNBC

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease

Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

TJ Biopharma Licenses Felzartamab to Biogen for Greater China in ~$850M Deal

Eli Lilly Reports Positive P-III (ACHIEVE-4) Data of Foundayo in Type 2 Diabetes and Obesity or Overweight

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