Health TidingsFDA Grants Priority Review to Cogent’s Bezuclastinib in Second-Line GIST FDA Grants Priority Review to Cogent’s Bezuclastinib in Second-Line GIST Read Post »
Clinical TrialsGSK’s Bepirovirsen Achieves Functional Cure in Phase 3 CHB Trials GSK’s Bepirovirsen Achieves Functional Cure in Phase 3 CHB Trials Read Post »
Health TidingsCorcept Plans NDA Resubmission for Relacorilant in Cushing’s Syndrome Corcept Plans NDA Resubmission for Relacorilant in Cushing’s Syndrome Read Post »
Health TidingsFDA Grants Breakthrough Therapy Designation to Terns’ TERN‑701 in CML FDA Grants Breakthrough Therapy Designation to Terns’ TERN‑701 in CML Read Post »
Health TidingsJapan Grants Orphan Drug Designation to Vanda’s Imsidolimab for GPP Japan Grants Orphan Drug Designation to Vanda’s Imsidolimab for GPP Read Post »
New Drug ApprovalIronwood and AbbVie Secure FDA Expansion for LINZESS in Young Children for ... Ironwood and AbbVie Secure FDA Expansion for LINZESS in Young Children for ... Read Post »
New Drug ApprovalFDA Clears AbbVie’s DECNUPAZ as First CD123 ADC for BPDCN FDA Clears AbbVie’s DECNUPAZ as First CD123 ADC for BPDCN Read Post »
Clinical TrialsAligos Shows Long-Term Pevifoscorvir Activity in Chronic HBV Aligos Shows Long-Term Pevifoscorvir Activity in Chronic HBV Read Post »
Health TidingsFDA Accepts NDA for BBP‑418 in LGMD2I/R9, Grants Priority Review FDA Accepts NDA for BBP‑418 in LGMD2I/R9, Grants Priority Review Read Post »
Clinical TrialsArrowhead Reports Liver Fat Reduction With ARO-INHBE in Obesity and MASH Arrowhead Reports Liver Fat Reduction With ARO-INHBE in Obesity and MASH Read Post »
Clinical TrialsBiohaven Shows Early Clinical Gains in Graves’ Disease and IgAN Biohaven Shows Early Clinical Gains in Graves’ Disease and IgAN Read Post »
Clinical TrialsAltimmune Reports Strong Fibrosis Improvements With Pemvidutide in MASH Altimmune Reports Strong Fibrosis Improvements With Pemvidutide in MASH Read Post »
Clinical TrialsGilead Presents Long-Term Livdelzi Phase 3 Results at EASL 2026 Gilead Presents Long-Term Livdelzi Phase 3 Results at EASL 2026 Read Post »
Health Tidings Mergers & AcquisitionsApogee Secures Up to $1.3 Billion From Blackstone to Advance Zumilokibart i... Apogee Secures Up to $1.3 Billion From Blackstone to Advance Zumilokibart i... Read Post »
Health TidingsFDA Begins Priority Review of Nuvalent’s Neladalkib After Accepting NDA FDA Begins Priority Review of Nuvalent’s Neladalkib After Accepting NDA Read Post »
Health TidingsFDA Extends Review of Camizestrant in ESR1‑Mutant Breast Cancer FDA Extends Review of Camizestrant in ESR1‑Mutant Breast Cancer Read Post »
Clinical TrialsIdefirix Advances Toward Full EU Approval After Positive PAES Results Idefirix Advances Toward Full EU Approval After Positive PAES Results Read Post »
Clinical TrialsLIB Showcases Long-Term LEROCHOL® Data at EAS 2026 LIB Showcases Long-Term LEROCHOL® Data at EAS 2026 Read Post »
Clinical TrialsSobi Reports 85% Lower Pancreatitis Risk with Olezarsen in sHTG Sobi Reports 85% Lower Pancreatitis Risk with Olezarsen in sHTG Read Post »
Health TidingsFDA OND Backs LYTENAVA Efficacy, Clearing Path Toward Approval FDA OND Backs LYTENAVA Efficacy, Clearing Path Toward Approval Read Post »
New Drug ApprovalApotex Wins Health Canada Approval for IHEEZO Eye Anesthetic Gel Apotex Wins Health Canada Approval for IHEEZO Eye Anesthetic Gel Read Post »
Clinical TrialsKura Reports Encouraging Responses in KRAS G12C Cancers at ASCO 2026 Kura Reports Encouraging Responses in KRAS G12C Cancers at ASCO 2026 Read Post »
Clinical TrialsBiohaven’s Opakalim Nears Regulatory Filing as Biohaven Reports New Epile... Biohaven’s Opakalim Nears Regulatory Filing as Biohaven Reports New Epile... Read Post »
Health Tidings Mergers & AcquisitionsLilly Acquires Curevo, LimmaTech, and Vaccine Company to Expand Vaccine Por... Lilly Acquires Curevo, LimmaTech, and Vaccine Company to Expand Vaccine Por... Read Post »
Clinical TrialsDyne Therapeutics Files BLA for DYNE‑251 in DMD Dyne Therapeutics Files BLA for DYNE‑251 in DMD Read Post »
ResearchNovo Nordisk Presents New Data on Residual Cardiovascular Inflammation Novo Nordisk Presents New Data on Residual Cardiovascular Inflammation Read Post »
Health TidingsAstellas Unveils Five-Year Growth Strategy Focused on Pipeline Expansion an... Astellas Unveils Five-Year Growth Strategy Focused on Pipeline Expansion an... Read Post »
Health TidingsPoolbeg Reports Positive FDA Meeting for POLB 001 CRS Program Poolbeg Reports Positive FDA Meeting for POLB 001 CRS Program Read Post »
New Drug ApprovalVyepti Wins South Korea Approval for Adult Migraine Vyepti Wins South Korea Approval for Adult Migraine Read Post »
Regulatory & Health PolicyChugai Wins Japan’s Top Invention Honor for Antibody Recycling Technology Chugai Wins Japan’s Top Invention Honor for Antibody Recycling Technology Read Post »
Regulatory & Health PolicyMHRA Proposes Accelerated Pathway for Rare Disease Therapies MHRA Proposes Accelerated Pathway for Rare Disease Therapies Read Post »
GenericsLupin Enters China With NMPA Approval for Pediatric Flu Drug Lupin Enters China With NMPA Approval for Pediatric Flu Drug Read Post »
Clinical TrialsLilly’s VERVE-102 Cuts LDL-C by Up to 62% in Phase 1b Heart-2 Study Lilly’s VERVE-102 Cuts LDL-C by Up to 62% in Phase 1b Heart-2 Study Read Post »
Health TidingsImmunovant Halts Batoclimab After Phase 3 TED Miss, Shifts Focus to IMVT‑... Immunovant Halts Batoclimab After Phase 3 TED Miss, Shifts Focus to IMVT‑... Read Post »
New Drug ApprovalEC Approves Pharming’s Joenja for Activated PI3K Delta Syndrome EC Approves Pharming’s Joenja for Activated PI3K Delta Syndrome Read Post »
Health TidingsGilead Advances Trodelvy in Europe With CHMP Nod for First-Line TNBC Gilead Advances Trodelvy in Europe With CHMP Nod for First-Line TNBC Read Post »
Drugs Safety AlertTakeda’s ADZYNMA Gets FDA Boxed Warning After Fatal Antibody Case Takeda’s ADZYNMA Gets FDA Boxed Warning After Fatal Antibody Case Read Post »
New Drug ApprovalGalderma Wins FDA Approval for OTC Differin Epiduo Acne Gel Galderma Wins FDA Approval for OTC Differin Epiduo Acne Gel Read Post »
Health TidingsCHMP Issues Positive Opinion for Camizestrant in ESR1‑Mutant Breast Cance... CHMP Issues Positive Opinion for Camizestrant in ESR1‑Mutant Breast Cance... Read Post »
Health TidingsCHMP Endorses Novo Nordisk’s Single-Dose Wegovy 7.2 mg Pen CHMP Endorses Novo Nordisk’s Single-Dose Wegovy 7.2 mg Pen Read Post »
New Drug ApprovalEC Grants EU‑Wide Approval for PYRUKYND in Thalassemia EC Grants EU‑Wide Approval for PYRUKYND in Thalassemia Read Post »
Clinical TrialsCHMP Backs AbbVie’s MAVIRET for Acute Hepatitis C in Adults and Children CHMP Backs AbbVie’s MAVIRET for Acute Hepatitis C in Adults and Children Read Post »
Clinical TrialsEli Lilly’s Foundayo Shows Up to 13% Weight Loss in Older Adults in ATTAI... Eli Lilly’s Foundayo Shows Up to 13% Weight Loss in Older Adults in ATTAI... Read Post »
New Drug ApprovalAstraZeneca and Daiichi Sankyo Secure FDA Approval for Datroway in Frontlin... AstraZeneca and Daiichi Sankyo Secure FDA Approval for Datroway in Frontlin... Read Post »
New Drug ApprovalGilead’s Hepcludex Becomes First FDA-Approved HDV Therapy Gilead’s Hepcludex Becomes First FDA-Approved HDV Therapy Read Post »
Health TidingsCHMP May 2026 Roundup: EU Backs New Treatments Across Oncology, Obesity, an... CHMP May 2026 Roundup: EU Backs New Treatments Across Oncology, Obesity, an... Read Post »
Health TidingsANKTIVA Plus BCG Shows Economic Edge in NMIBC CIS ANKTIVA Plus BCG Shows Economic Edge in NMIBC CIS Read Post »
Clinical TrialsInnovent’s IBI363 Demonstrates Durable Efficacy in NSCLC Innovent’s IBI363 Demonstrates Durable Efficacy in NSCLC Read Post »
Health TidingsRegeneron’s Otarmeni™ Accepted for EMA Review Under Accelerated Assessm... Regeneron’s Otarmeni™ Accepted for EMA Review Under Accelerated Assessm... Read Post »
Clinical TrialsBoehringer Ingelheim Unveils New Zongertinib and Obrixtamig Results Across ... Boehringer Ingelheim Unveils New Zongertinib and Obrixtamig Results Across ... Read Post »
