Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe

Shots: Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the…

ByRidhi RastogiAugust 25, 2026

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GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…

ByRidhi RastogiAugust 25, 2026

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J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts…

ByRidhi RastogiAugust 25, 2026

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Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…

ByRidhi RastogiAugust 24, 2026

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Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…

ByRidhi RastogiAugust 24, 2026

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Shots: The EC has approved Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.) across all 30 EEA states Approval was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale co-1EPs Daybu, a synthetic analog…

ByRidhi RastogiAugust 24, 2026

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Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

Shots: Alvotech has entered a strategic licensing & commercialization agreement with Lotus Pharmaceutical for AVT34, a proposed Imfinzi (durvalumab) biosimilar, & AVT87, a proposed Hemlibra (emicizumab) biosimilar, in the US & selected Asian markets Under the US semi-exclusive deal, Alvotech & Lotus will jointly commercialize AVT34 and AVT87, with Lotus commercializing the products through Alvogen;…

ByRidhi RastogiAugust 24, 2026

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Hanmi Pharm Licenses HM17321 to Genentech in ~$2.3B Deal

Shots: Hanmi Pharm has entered into an exclusive licensing agreement with Genentech for the development, manufacturing, & commercialization of HM17321, for obesity & associated conditions such as T2D & CV diseases, globally, excl. South Korea As per the deal, Hanmi will receive ~$190M upfront, with additional development, regulatory & commercial milestones representing the total deal…

ByRidhi RastogiAugust 24, 2026

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Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

ByRidhi RastogiAugust 24, 2026

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DeepCyte Launches AI Toxicology Atlas to Predict Drug Safety Risks

Shots: DeepCyte has launched DeeTox Atlas, the first single-cell metabolomic reference atlas for drug toxicity mechanisms, with enterprise pilots set to begin soon & three of the top 20 pharma companies already in pilot discussions Platform is built from 2 independent studies covering ~100 toxicant compounds, 300k cells & ~500 metabolites/cell, generating 3,000+ single-cell measurements…

ByRidhi RastogiAugust 19, 2026

Ridhi Rastogi

Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

Hanmi Pharm Licenses HM17321 to Genentech in ~$2.3B Deal

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

DeepCyte Launches AI Toxicology Atlas to Predict Drug Safety Risks

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