EMA Marketing Authorization of New Drugs in June 2026

Shots: The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon. European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…

ByDipanshu Dixit7 hours ago

TOP 20

Top 20 Immunology Companies of 2026

Shots: AbbVie led the global immunology market with $30.4B in immunology revenue in 2025, followed by Sanofi ($19.08B) and Johnson & Johnson ($15.72B). Continued demand for biologics and targeted therapies across autoimmune and inflammatory diseases supported strong commercial performance among leading companies. The global immunology market, valued at $108.4B in 2024, is projected to…

ByPrince Giri4 days ago

NEWS

Aqemia Expands Sanofi Collaboration With New Target Nomination

Shots: Aqemia has expanded its multi-year research collaboration with Sanofi, marked by the nomination of a new therapeutic target & an additional payment The collaboration, initially announced in Dec 2023, makes Aqemia eligible to receive up to a total of $140M in upfront & milestone payments across programs Aqemia uses its physics-based generative AI platform,…

ByRidhi Rastogi4 days ago

NEWS

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Shots: The US has approved Sarclisa Escena (isatuximab-irfc; SC) + SoC for the treatment of pts with MM across all existing indications of Sarclisa IV formulation Approval was backed by multiple trials, incl. P-III (IRAKLIA) in R/R MM, which showed shorter treatment time & fewer infusion-related reactions with Sarclisa Escena In IRAKLIA, SC Sarclisa delivered…

ByRidhi RastogiJuly 13, 2026

NEWS

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…

ByRidhi RastogiJune 30, 2026

NEWS

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

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…

ByRidhi RastogiJune 15, 2026

NEWS

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi RastogiMay 28, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026

Shots: The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…

ByDipanshu DixitMay 19, 2026

EMA Marketing Authorization of New Drugs in June 2026

Top 20 Immunology Companies of 2026

Aqemia Expands Sanofi Collaboration With New Target Nomination

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

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)

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

EMA Marketing Authorization of New Drugs in April 2026

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