Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis
Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...
TKIs (EGFR VEGF BTK etc.)
Novartis’ Remibrutinib Wins CHMP Positive Opinion – Oral BTK Inhibitor Nears EU Approval for Chronic Urticaria
Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...
Eli Lilly’s Jaypirca Wins NMPA Approval for CLL/SLL Post-BTK Inhibitor Therapy
Eli Lilly and Company (NYSE: LLY) announced that the National Medical Products Administration (NMPA) has approved...
Fosun Pharma’s Fumaining Wins Priority Review for NF1 Adult Indication in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that the National Medical Products...
TYK Medicines Asandeutertinib Gets China Priority Review for NSCLC Brain Metastases
TYK Medicines, Inc. (HKG: 2410) announced that its Category 1 drug asandeutertinib (TY‑9591), a third‑generation EGFR...
Merck and Abbisko’s Pimicotinib NDA Accepted by FDA for TGCT, Building on China Approval
Merck KGaA (ETR: MRK) and Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. FDA...
Boehringer Ingelheim & Jazz Launch Phase I HER2 Breast Cancer Combo with Zongertinib & Zanidatamab
Boehringer Ingelheim and Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced a strategic clinical collaboration to evaluate a...
Hansoh Pharmaceutical’s Ameile Wins Fifth NMPA Indication for EGFR‑Mutated NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that its core product, Ameile (almonertinib), has...
Sciclon Licenses Augtyro Promotion Rights from Zai Lab for China Market
Sciclon Pharmaceuticals (HKG: 6600) forged a collaboration with Zai Lab (NASDAQ: ZLAB, HKG: 9688), securing exclusive promotional rights...
Bayer’s Cevatertinib Wins Breakthrough Therapy Designation for HER2‑Mutant NSCLC
Bayer AG (VIE: BAYN) announced that cevatertinib (BAY 2927088) has been granted Breakthrough Therapy Designation (BTD)...
HutchMed’s Savolitinib NDA Accepted by NMPA for MET-Amplified Gastric Cancer with Priority Review
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
HutchMed’s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Allist Pharmaceuticals Secures Breakthrough Therapy Designation for Furmonertinib in EGFR PACC‑Mutated NSCLC
Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that furmonertinib has been added to the Breakthrough...
Takeda Zasocitinib TYK2 Phase III Shows Positive Psoriasis Results
Takeda Pharmaceutical Company (TYO: 4502, NYSE: TAK) announced positive topline results from two pivotal Phase III...
Merck’s Pimicotinib Wins China Approval as First Class 1 Therapy for TGCT
Merck KGaA (ETR: MRK) announced that China’s National Medical Products Administration (NMPA) granted priority review approval...
TransThera NDA Accepted for Tinengotinib in Cholangiocarcinoma After FGFR Inhibitor
TransThera Sciences (Nanjing), Inc. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) formally...
Hansoh Licenses EGFR Drug Aumolertinib to Glenmark for $1B+ in Milestones
Jiangsu Hansoh Pharmaceutical Co. Ltd. (HKG: 3692) entered into an exclusive license, collaboration, and distribution...
TransThera Tinengotinib Cholangiocarcinoma Priority Review China
TransThera Sciences (Nanjing) Inc. (HKG: 2617) announces that Tinengotinib tablets have been included in the...
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...