LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Shots: The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs. Additionally, LENZ…

ByRidhi RastogiMarch 11, 2026

NEWS

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

ByRidhi RastogiMarch 10, 2026

NEWS

BMS Reports P-II/III (SUCCESSOR-2) Trial Data on Mezigdomide Combination for R/R Multiple Myeloma

Shots: BMS has reported the P-II/III (SUCCESSOR-2) trial data assessing mezigdomide (PO) + carfilzomib & dexamethasone vs carfilzomib & dexamethasone alone in pts with r/r multiple myeloma The P-III portion showed improved PFS (1EP), with safety consistent with the known profile of the regimen & mezigdomide. The trial will continue to follow pts for survival…

ByRidhi RastogiMarch 10, 2026

NEWS

Rapport Therapeutics Partners with Tenacia Biotechnology to Advance RAP-219 in Greater China

Shots: Rapport Therapeutics has granted Tenacia exclusive rights to develop & commercialize RAP-219 in Greater China across indications, incl. focal onset seizures (FOS) & bipolar mania, with Rapport retaining rights in other territories As per the deal, Rapport will receive $20M upfront & ~$308M in development & commercialization milestones & other payments, plus mid-single digits…

ByRidhi RastogiMarch 10, 2026

NEWS

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

Shots: FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…

ByRidhi RastogiMarch 9, 2026

NEWS

GSK Licenses Linerixibat’s Global Rights to Alfasigma in ~$690M Deal

Shots: GSK has granted Alfasigma worldwide exclusive rights to develop, manufacture & commercialise linerixibat for cholestatic pruritus in primary biliary cholangitis As per the deal, GSK will receive $300M upfront, $100M upon FDA approval (based on PDUFA date of Mar 24, 2026), $20M upon EU & UK approval, & ~$270M in sales milestones, along with…

ByRidhi RastogiMarch 9, 2026

NEWS

Incyte’s Zynyz Receives the EC Approval to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The EC has approved Zynyz (retifanlimab) + Pt-based CT for the 1L treatment of adults with metastatic or inoperable locally recurrent SCAC Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts The trial showed a 37% reduction in the risk of progression or…

ByRidhi RastogiMarch 9, 2026

NEWS

BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA approved Sotyktu(6mg, PO, QD) for adults with active PsA based on 2 P-III trials against PBO, with POETYK PsA-1 involving 670 bDMARD-naïve pts while POETYK PsA-2 involved 624 pts who were bDMARD-naïve & treated with prior TNFα inhibitor POETYK PsA-1 showed that 54% pts achieved ACR20 compared to 34%, while 24% vs 14%…

ByRidhi RastogiMarch 9, 2026

NEWS

Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

Shots: The US FDA has approved Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab & hyaluronidase-fihj) for the treatment of adults with r/r MM, who have received ≥1L of prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent Approval was based on the ongoing P-III (MajesTEC-3) study evaluating Tecvayli + Darzalex vs investigator’s choice of Darzalex & dexamethasone with…

ByRidhi RastogiMarch 6, 2026

NEWS

Teva Lands $400M Blackstone Life Sciences Deal to Support Duvakitug Development

Shots: Teva & Blackstone Life Sciences have entered a four-year strategic funding agreement to support the continued clinical development of duvakitug As per the deal, Blackstone will provide $400M to Teva over four years to fund duvakitug development, while Blackstone will receive potential milestone payment subject to FDA approval, & additional commercial milestones, as well…

ByRidhi RastogiMarch 5, 2026

LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

BMS Reports P-II/III (SUCCESSOR-2) Trial Data on Mezigdomide Combination for R/R Multiple Myeloma

Rapport Therapeutics Partners with Tenacia Biotechnology to Advance RAP-219 in Greater China

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

GSK Licenses Linerixibat’s Global Rights to Alfasigma in ~$690M Deal

Incyte’s Zynyz Receives the EC Approval to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

Teva Lands $400M Blackstone Life Sciences Deal to Support Duvakitug Development

Contact US

FOLLOW US