Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses

Shots: The EC has approved Cenrifki (PO, QD) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last 2yrs. Approval was backed by P-III (HERCULES) trial (vs PBO) in non-relapsing SPMS (nrSPMS) & supporting data from P-III (GEMINI 1 & 2) studies (vs teriflunomide) in relapsing MS, with HERCULES demonstrating delayed…

ByRidhi RastogiJune 23, 2026

NEWS

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Shots: The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review Approval was based on the P-III (IRAKLIA) study in R/R…

ByRidhi RastogiJune 19, 2026

NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

Shots: The MHLW has approved Minjuvi (tafasitamab) + Lenalidomide for the treatment of adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) Approval was based on the international P-II (L-MIND) trial, & a Japanese P-Ib/II (J-MIND) trial (Group 6) assessing Minjuvi + lenalidomide in pts with r/r DLBCL who are not eligible for autologous stem…

ByRidhi RastogiJune 19, 2026

NEWS

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Shots: The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts Capvaxive…

ByRidhi RastogiJune 19, 2026

NEWS

Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Shots: The US FDA has received an NDA for ecopipam, a selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome NDA was supported by the P-III trial data showing that ecopipam significantly delayed time to relapse vs PBO in pediatric Tourette syndrome pts who responded to treatment during the open-label treatment period;…

ByRidhi RastogiJune 19, 2026

NEWS

Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

Shots: The US FDA has accepted sBLA for Genentech's Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027) sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above…

ByRidhi RastogiJune 18, 2026

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F2G and Shionogi Report Topline P-III (OASIS) Trial Results on Olorofim in Invasive Aspergillosis

Shots: F2G & Shionogi have reported the topline P-III (OASIS) trial data assessing olorofim (PO) vs AmBisome followed by SoC in 225 pts with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy Trial met its 1EP of non-inferiority, with a rate of all-cause mortality of 23.8% vs 24.3% at Day 42,…

ByRidhi RastogiJune 18, 2026

NEWS

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026 Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…

ByRidhi RastogiJune 18, 2026

NEWS

Dimerix Inks a ~$340M Deal with Everest Medicine to Commercialize DMX-200 in Greater China, South Korea, and Southeast Asia

Shots: Dimerix has granted Everest exclusive rights to commercialize DMX-200 for all indications incl. FSGS, in Greater China, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam & Philippines; Dimerix will retain rights outside the licensed regions Dimerix will continue funding & conducting the P-III (ACTION3) study, while Everest will manage regulatory filings, maintenance of the regulatory…

ByRidhi RastogiJune 16, 2026

NEWS

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

Shots: The Takeda's P-III (FirstLight & RadiantLight) trial assessed oveporexton (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO), while RadiantLight randomized 105 pts to two arms (2mg & PBO); regulatory filing is under review in the US (priority review), China & Japan At Wk. 12,…

ByRidhi RastogiJune 16, 2026

Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

F2G and Shionogi Report Topline P-III (OASIS) Trial Results on Olorofim in Invasive Aspergillosis

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Dimerix Inks a ~$340M Deal with Everest Medicine to Commercialize DMX-200 in Greater China, South Korea, and Southeast Asia

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

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