Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label Read Post »
New Drug ApprovalAstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... AstraZeneca’s Triple-combination inhaler Breztri approved by FDA for asth... Read Post »
Clinical TrialsBoehringer’s survodutide Achieves Up to 16.6% Weight Loss in Phase II... Boehringer’s survodutide Achieves Up to 16.6% Weight Loss in Phase II... Read Post »
Clinical TrialsAbbVie Files Upadacitinib for FDA Approval in Alopecia Areata AbbVie Files Upadacitinib for FDA Approval in Alopecia Areata Read Post »
Health TidingsJanux discontinues JANX008 after Phase 1a results over efficacy Janux discontinues JANX008 after Phase 1a results over efficacy Read Post »
Health TidingsGilead Completes $7.8 Billion Acquisition of Arcellx, Gains Full Control of... Gilead Completes $7.8 Billion Acquisition of Arcellx, Gains Full Control of... Read Post »
Health TidingsTerns Advances TERN-701 with FDA Breakthrough Therapy Designation in CML Terns Advances TERN-701 with FDA Breakthrough Therapy Designation in CML Read Post »
Clinical TrialsMundipharma Positions REZZAYO as a Steady Shield in Fungal Prevention Study Mundipharma Positions REZZAYO as a Steady Shield in Fungal Prevention Study Read Post »
Health TidingsFDA Seeks to Withdraw TAVNEOS After Identifying Efficacy Gaps FDA Seeks to Withdraw TAVNEOS After Identifying Efficacy Gaps Read Post »
Clinical TrialsOruka Therapeutics Reports Strong 16-Week Results for ORKA-001 in Psoriasis Oruka Therapeutics Reports Strong 16-Week Results for ORKA-001 in Psoriasis Read Post »
Health TidingsJohnson & Johnson Secures FDA Priority Review for IMAAVY® in wAIHA Johnson & Johnson Secures FDA Priority Review for IMAAVY® in wAIHA Read Post »
Health TidingsOncolytics Biotech Aligns with FDA on Pivotal Trial Design for Pelareorep i... Oncolytics Biotech Aligns with FDA on Pivotal Trial Design for Pelareorep i... Read Post »
New Drug ApprovalNovartis Targets the Root of CSU With EU Approval of Rhapsido Novartis Targets the Root of CSU With EU Approval of Rhapsido Read Post »
Clinical TrialsIntellia Backs Lonvo-z as One-Time CRISPR Therapy for HAE in Phase 3 HAELO Intellia Backs Lonvo-z as One-Time CRISPR Therapy for HAE in Phase 3 HAELO Read Post »
Health TidingsGSK moves efimosfermin forward with dual US FDA Breakthrough and EMA PRIME ... GSK moves efimosfermin forward with dual US FDA Breakthrough and EMA PRIME ... Read Post »
Health TidingsJazz Marks FDA Acceptance, Priority Review Milestone for Zanidatamab Jazz Marks FDA Acceptance, Priority Review Milestone for Zanidatamab Read Post »
New Drug ApprovalJohnson & Johnson Gains FDA Nod for CAPLYTA in Schizophrenia Johnson & Johnson Gains FDA Nod for CAPLYTA in Schizophrenia Read Post »
Health TidingsAbbVie Steps Beyond Infusion with SC SKYRIZI Filing in Crohn’s Disease AbbVie Steps Beyond Infusion with SC SKYRIZI Filing in Crohn’s Disease Read Post »
Health Tidings Mergers & AcquisitionsBioMarin Bolsters Its Rare Disease Portfolio Through Amicus Acquisition BioMarin Bolsters Its Rare Disease Portfolio Through Amicus Acquisition Read Post »
Health TidingsGSK stands firm on Jemperli as AnaptysBio seeks to reclaim rights GSK stands firm on Jemperli as AnaptysBio seeks to reclaim rights Read Post »
Mergers & AcquisitionsEli Lilly Bets Big on Next-Gen JAK2 Science with Ajax Therapeutics Deal Eli Lilly Bets Big on Next-Gen JAK2 Science with Ajax Therapeutics Deal Read Post »
New Drug ApprovalAstraZeneca Clinches FDA Approval for Saphnelo Autoinjector in SLE AstraZeneca Clinches FDA Approval for Saphnelo Autoinjector in SLE Read Post »
Clinical TrialsZydus Takes Zintrodiazine to Phase III After DCGI Clearance in India Zydus Takes Zintrodiazine to Phase III After DCGI Clearance in India Read Post »
GenericsAlembic Secures USFDA Approval for Fingolimod capsules for MS Alembic Secures USFDA Approval for Fingolimod capsules for MS Read Post »
Health Tidings Mergers & AcquisitionsSun Pharma Acquires Organon in $11.75 Billion Deal Sun Pharma Acquires Organon in $11.75 Billion Deal Read Post »
Mergers & AcquisitionsSerum Institute Joins VaxThera to Expand Vaccine Access in Colombia Serum Institute Joins VaxThera to Expand Vaccine Access in Colombia Read Post »
Mergers & AcquisitionsSerum Institute of India Teams with Oxford to Reinforce the Fight Against M... Serum Institute of India Teams with Oxford to Reinforce the Fight Against M... Read Post »
New Drug ApprovalCHMP April 2026 Roundup: Breakthroughs in SMA, MS, and Rare Metabolic Disor... CHMP April 2026 Roundup: Breakthroughs in SMA, MS, and Rare Metabolic Disor... Read Post »
Health TidingsCompass Pathways gains priority voucher, speeds COMP360 review Compass Pathways gains priority voucher, speeds COMP360 review Read Post »
Health TidingsNovartis Pulls Back Pluvicto as CHMP Raises Red Flag Novartis Pulls Back Pluvicto as CHMP Raises Red Flag Read Post »
Regulatory & Health PolicyWHO Prequalification Elevates Novartis’ Coartem Baby in Malaria Care for ... WHO Prequalification Elevates Novartis’ Coartem Baby in Malaria Care for ... Read Post »
Disease & DrugsJohnson & Johnson to Acquire Atraverse Medical, Expanding Cardiac Ablat... Johnson & Johnson to Acquire Atraverse Medical, Expanding Cardiac Ablat... Read Post »
Regulatory & Health PolicyFDA Accelerates the Clock on Psychedelic Research After Federal Order FDA Accelerates the Clock on Psychedelic Research After Federal Order Read Post »
Health TidingsGrace Therapeutics Hits CRL Wall in GTx-104 Approval Bid Grace Therapeutics Hits CRL Wall in GTx-104 Approval Bid Read Post »
Health TidingsAstellas Amends Mirabegron Deal with MSN, Secures $75 Million Upfront Astellas Amends Mirabegron Deal with MSN, Secures $75 Million Upfront Read Post »
Clinical TrialsKyowa Kirin, Kura Oncology Dose First Patient in Japan Ziftomenib Study Kyowa Kirin, Kura Oncology Dose First Patient in Japan Ziftomenib Study Read Post »
Health Tidings Mergers & AcquisitionsAbbVie Receives FDA Complete Response Letter for TrenibotulinumtoxinE AbbVie Receives FDA Complete Response Letter for TrenibotulinumtoxinE Read Post »
New Drug ApprovalRegeneron Breaks the Silence with Otarmeni, a First-in-Class Hearing Loss G... Regeneron Breaks the Silence with Otarmeni, a First-in-Class Hearing Loss G... Read Post »
Mergers & AcquisitionsApotex to Acquire Cumberland’s Branded Drug Portfolio in $100M Deal Apotex to Acquire Cumberland’s Branded Drug Portfolio in $100M Deal Read Post »
Health TidingsConnect Biopharma Stays the Course as Rademikibart Meets Interim Benchmarks Connect Biopharma Stays the Course as Rademikibart Meets Interim Benchmarks Read Post »
Clinical TrialsCatalYm Targets the Root of Cancer-Linked Wasting in VINCIT Trial CatalYm Targets the Root of Cancer-Linked Wasting in VINCIT Trial Read Post »
Clinical TrialsNeurocrine Charts a Lower-Steroid Future for CAH With Crinecerfont Data Neurocrine Charts a Lower-Steroid Future for CAH With Crinecerfont Data Read Post »
Clinical TrialsNovo Nordisk Reports Positive PIONEER TEENS Results for Oral Semaglutide Novo Nordisk Reports Positive PIONEER TEENS Results for Oral Semaglutide Read Post »
Clinical TrialsCapricor Reports Phase 3 HOPE-3 Results for Deramiocel in Duchenne Capricor Reports Phase 3 HOPE-3 Results for Deramiocel in Duchenne Read Post »
ManufacturingMHRA Recalls Napralief Painkiller Over Missing Safety Information MHRA Recalls Napralief Painkiller Over Missing Safety Information Read Post »
Clinical TrialsKyverna Advances Miv-cel with Positive Registrational Data in Rare Neurolog... Kyverna Advances Miv-cel with Positive Registrational Data in Rare Neurolog... Read Post »
GenericsCipla Expands U.S. Presence with Approval of Generic Albuterol Inhaler Cipla Expands U.S. Presence with Approval of Generic Albuterol Inhaler Read Post »
CRO Medical DevicesLabcorp Expands Newly Approved PD-L1 Assay, Enabling Rapid Identification o... Labcorp Expands Newly Approved PD-L1 Assay, Enabling Rapid Identification o... Read Post »
New Drug ApprovalDupixent Breaks New Ground in Pediatric Chronic Urticaria Care Dupixent Breaks New Ground in Pediatric Chronic Urticaria Care Read Post »
Health Tidings Mergers & AcquisitionsAmneal Bets Big on Biosimilars with Kashiv Acquisition Amneal Bets Big on Biosimilars with Kashiv Acquisition Read Post »
Health TidingsModerna Steps Up the Guard with Phase 3 Trial for Bird Flu Vaccine Moderna Steps Up the Guard with Phase 3 Trial for Bird Flu Vaccine Read Post »
