Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

Shots: The EMA has validated the MAA for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application developed in collaboration between Pfizer & Valneva The application is supported by >70% efficacy in the P-III (VALOR) trial, which evaluated PF-07307405 in individuals aged ≥5 years.…

ByRidhi RastogiAugust 14, 2026

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BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

Shots: FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd;…

ByRidhi RastogiAugust 14, 2026

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Definium Therapeutics Reports P-III (Voyage) Study on DT120 ODT in Generalized Anxiety Disorder (GAD)

Shots: Definium has reported topline P-III (Voyage) trial results assessing DT120 (lysergide, Orally Disintegrating Tablet, 100µg; n=107) vs PBO (n=107) in 214 adults with GAD Voyage met its 1EP, with DT120 improving HAM-A scores at Wk. 12 (-11.6 vs -6.2). Efficacy emerged by Day 2 & was sustained through all post-baseline timepoints in Part A Key…

ByRidhi RastogiAugust 13, 2026

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Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC

Shots: The companies have reported the global P-III (REZILIENT3) trial assessing zipalertinib + Pt-based CT vs CT alone in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations Trial met its 1EP of PFS, showing improvement with the zipalertinib-containing regimen at interim analysis, with the IDMC recommending unblinding the…

ByRidhi RastogiAugust 13, 2026

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Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Shots: The US FDA has accepted & granted Priority Review to the NDA for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1), with a PDUFA target date of Feb 12, 2027 NDA was supported by the P-III (DRAGON) trial assessing tinlarebant vs PBO in STGD1 pts, showing 35.7% reduction in atrophic retinal lesion growth…

ByRidhi RastogiAugust 12, 2026

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Mereo BioPharma and Sentynl Therapeutics Ink ~$475M Pact for Alvelestat

Shots: Sentynl, a subsidiary of Zydus, has entered into an option & license agreement with Mereo for the US commercial & global manufacturing rights to alvelestat for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD) Sentynl will have an exclusive option to license alvelestat in the US, while Mereo retains ex-US commercial rights; Sentynl will also hold…

ByRidhi RastogiAugust 12, 2026

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Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

Shots: Silence has reported topline P-II (SANRECO) trial results assessing divesiran (6mg/kg, SC, Q6W or Q12W) vs PBO in 48 phlebotomy-dependent patients with polycythemia vera (PV); P-III PV trial for Q12W dosing to initiate in H1’27 Trial met its 1EP, with significantly more PV pts responding to divesiran vs PBO (88% vs 19%). Response was…

ByRidhi RastogiAugust 11, 2026

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Innate Pharma Collaborates with Sobi to License Lacutamab in Cutaneous T-cell Lymphoma (CTCL)

Shots: Innate Pharma & Sobi have entered into a strategic partnership to initiate P-III (TELLOMAK-3) trial of lacutamab in CTCL, supporting a planned accelerated approval filing in Sézary syndrome TELLOMAK-3 is expected to support full approval filings in Sézary syndrome & mycosis fungoides. Sobi will gain exclusive global commercialization rights upon potential accelerated approval &…

ByRidhi RastogiAugust 10, 2026

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Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

Shots: Health Canada has approved Libtayo (cemiplimab) for the adj. treatment of adults with CSCC who are at high risk for recurrence after surgery & radiation Approval was based on the P-III (C-POST) trial assessing adj. Libtayo (n=209) vs PBO (n=206) to treat high-risk CSCC pts (N=415) Trial showed a 68% reduction in disease recurrence…

ByRidhi RastogiAugust 7, 2026

NEWS

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Shots: FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…

ByRidhi RastogiAugust 7, 2026

Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

Definium Therapeutics Reports P-III (Voyage) Study on DT120 ODT in Generalized Anxiety Disorder (GAD)

Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC

Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Mereo BioPharma and Sentynl Therapeutics Ink ~$475M Pact for Alvelestat

Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

Innate Pharma Collaborates with Sobi to License Lacutamab in Cutaneous T-cell Lymphoma (CTCL)

Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

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