Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Shots: The EC has granted conditional approval to Ipsen's Ojemda as a monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy, across all 30 EEA states Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…

ByRidhi RastogiApril 22, 2026

NEWS

Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC

Shots: Akeso has reported the P-II (COMPASSION-26) trial results assessing cadonilimab + CT as the 1L treatment of advanced pancreatic ductal adenocarcinoma (PDAC) As of Oct 20, 2025 (mFU of >2yrs.), trial showed robust & durable survival benefits, with mPFS of 11.1mos. & mOS of >23mos., showing 12 & 24mos. OS rate of 91.7% &…

ByRidhi RastogiApril 21, 2026

NEWS

Aligos Therapeutics Licenses Pevifoscorvir Sodium to Xiamen Amoytop Biotech for Greater China

Shots: Aligos has entered into an exclusive license agreement with Xiamen Amoytop Biotech, granting Amoytop rights to develop & commercialize pevifoscorvir sodium in Greater China for chronic hepatitis B virus (HBV) infection As per the deal, Aligos will receive an $25M upfront & ~$420M in clinical, regulatory, & sales milestones along with tiered, high single-digit…

ByRidhi RastogiApril 16, 2026

NEWS

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

Shots: FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026) BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in…

ByRidhi RastogiApril 14, 2026

NEWS

BioNTech Reports Positive P-II Data of Trastuzumab Pamirtecan in HER2-Expressing Endometrial Cancer

Shots: BioNTech reported positive results from a P-II study cohort of trastuzumab pamirtecan (BNT323/DB-1303) in HER2-expressing recurrent endometrial cancer, meeting its 1EP of ORR The study cohort (n=145) demonstrated a confirmed ORR of 47.9% (n=96; central testing) and 49.3% in pts. (n=73) previously treated with checkpoint inhibitors, with a mPFS of 8.1mos., showing consistent efficacy…

ByPrince GiriApril 13, 2026

NEWS

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

ByRidhi RastogiApril 8, 2026

NEWS

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Shots: Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…

ByRidhi RastogiApril 7, 2026

NEWS

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Shots: Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…

ByRidhi RastogiApril 7, 2026

NEWS

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Shots: The P-Ib/II trial randomized 67 MSS CRC pts (65 evaluable) with no liver metastases to muzastotug (10mg/kg; Q3W or Q6W) or muzastotug (20mg/kg) followed by 10mg/kg (Q3W), or 20 mg/kg (Q6W), all in combination with Keytruda; P-II data expected in H1’27 As of Jan 24, 2026, pts in 10mg/kg cohorts (N=39) showed ORR of…

ByRidhi RastogiApril 6, 2026

NEWS

Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026

Shots: Abcuro has reported the P-II/III (MUSCLE) trial data assessing ulviprubart (ABC008; Q8W) in 272 IBM pts randomized to either 0.5mg/kg (n=94, Low Dose), 2mg/kg (n=92, High Dose), or PBO (n=86) Across all pts, the 1EP showed a trend toward slower IBMFRS decline at Wk. 76, with a 1.7-point decrease in the low-dose group vs…

ByRidhi RastogiMarch 27, 2026

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC

Aligos Therapeutics Licenses Pevifoscorvir Sodium to Xiamen Amoytop Biotech for Greater China

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

BioNTech Reports Positive P-II Data of Trastuzumab Pamirtecan in HER2-Expressing Endometrial Cancer

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026

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