News

The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.

SpringWorks Therapeutics receives FDA approval for GOMEKLI™ (mirdametinib) to treat adults and children with NF1-PN.

Wednesday, February 12, 2025

SpringWorks Therapeutics has received FDA approval for GOMEKLI mirdametinib a MEK inhibitor to treat adults and children aged two years and older with neurofibromatosis type NF who have symptomatic plexiform neurofibromas PN that cannot be fully rem...

Novartis to expand late-stage cardiovascular portfolio with USD 925 million acquisition of Anthos Therapeutics

Tuesday, February 11, 2025

Novartis has signed an agreement to acquire Anthos Therapeutics a Bostonbased clinicalstage biopharmaceutical company Anthos Therapeutics is developing abelacimab a latestage treatment aimed at preventing stroke and systemic embolism in patients with...

Immix Biopharma gains FDA Regenerative Medicine Advanced Therapy designation for NXC-201, an optimised CAR-T treatment for relapsed or refractory AL amyloidosis

Tuesday, February 11, 2025

Immix Biopharma a clinicalstage biopharmaceutical company focused on cell therapies for AL amyloidosis and immunemediated diseases has received Regenerative Medicine Advanced Therapy RMAT designation from the US Food and Drug Administration FDA for N...

Keymed Biosciences Announces Approval of Stapokibart For the Treatment of Seasonal Allergic Rhinitis

Monday, February 10, 2025

Keymed Biosciences announced the National Medical Products Administration the NMPA of China has recently approved the supplemental New Drug Application the sNDA of Stapokibart antiILR monoclonal antibody trade name Kangyueda

U.S. FDA Awards Orphan Drug Status to Ariceum Therapeutics' Exclusive Radiopharmaceutical Cancer Treatment

Friday, February 07, 2025

Ariceum Therapeutics a private biotech company focused on developing radiopharmaceutical treatments for diagnosing and treating certain difficulttotreat cancers has received Orphan Drug Status from the US Food and Drug Administration FDA for AcSSO sa...

Adicet Bio Granted FDA Fast Track Status for ADI-001 in Treatment of Refractory Systemic Lupus Erythematosus with Extrarenal Involvement

Thursday, February 06, 2025

Adicet Bio Inc a clinicalstage biotechnology company focused on discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer has announced that the US Food and Drug Administration

Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale, and Clinical Supplies

Thursday, February 06, 2025

Recipharm a global leader in contract development and manufacturing has announced that a new modular sterile filling system designed for process development pilot scale and clinical supply is now fully operational at its advanced facility in Wasserbu...

Supernus Receives FDA Approval for ONAPGO™ (Apomorphine Hydrochloride) to Treat Parkinson’s Disease

Wednesday, February 05, 2025

Supernus Pharmaceuticals Inc a biopharmaceutical company focused on developing and marketing treatments for central nervous system CNS diseases has received approval from the US Food and Drug Administration FDA for ONAPGO apomorphine hydrochloride in...

COUR Pharmaceuticals receives FDA approval for IND application of CNP-103 for Type 1 diabetes.

Wednesday, February 05, 2025

COUR Pharmaceuticals a biotechnology company focused on developing treatments for immunerelated diseases has received approval from the US Food and Drug Administration FDA for its Investigational New Drug IND application for CNP This nanoparticle the...

Purple Biotech to Collaborate with Icahn School of Medicine at Mount Sinai on CAPTN-3 Tri-Specific Antibody Platform Research

Tuesday, February 04, 2025

Purple Biotech Ltda clinicalstage company focused on developing therapies to address tumour immune evasion and drug resistance has signed a Research Collaboration Agreement with the Icahn School of Medicine at Mount Sinai in New York