Migraine
May 20, 2025
Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+
Incyte’s ZYNYZ Approved by FDA as First-Line Treatment for Advanced Anal Cancer The FDA approved ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor developed by Incyte, for the treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The approval incl...
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Feb 04, 2025
AstraZeneca Scraps £450M UK Vaccine Factory; FDA Approves First Non-Opioid Pain Reliever JOURNAVX in 20+ Years; Axsome’s SYMBRAVO Wins FDA Nod for Migraine; March Biosciences’ MB-105 Gains FDA Orphan Status for T-Cell Lymphoma; Saol’s SL1009 NDA Accepted for Pyruvate Dehydrogenase Complex Deficiency
AstraZeneca Scraps £450M Vaccine Factory in UK, Dealing a Blow to Reeves AstraZeneca has withdrawn its planned £450 million investment to expand a vaccine manufacturing facility in Liverpool, citing reduced financial support from the new Labour government. Initially announced in the previous Conservative governm...
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Dec 21, 2023
Integra to Buy J&J’s Acclarent; B. Braun Launches the CARESITE Micro Luer Access Devic; FDA Approves Medtronic’s Novel PulseSelect Pulsed Field Ablation System; FDA Clearances to Perfuze’s Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment; ShiraTronics Successfully Implants First Migraine System; Sight Sciences Announced the Six-Month Results For Heat Therapy Device
Integra LifeSciences to Buy Johnson & Johnson’s Acclarent and its ENT Tech On December 13, 2023, Integra LifeSciences entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent strengthens Integra's position in the ENT treatment market. Acclarent is a component of ...
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Jun 27, 2023
FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma
FDA Approves Jardiance for the Treatment of Type 2 Diabetes in Children 10 Years and Older Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years and older w...
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Mar 23, 2023
Viz.ai’s AI Algorithm for Abdominal Aortic Aneurysm; BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care; Medtronic and NVIDIA Announces Collaboration; Median Technologies Announces Update for its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device
Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to ...
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Jul 19, 2022
Byondis’s HER2-targeting ADC trastuzumab duocarmazine; AbbVie Migraine Drug Atogepant; Grünenthal Acquires Bayer’s Testosterone Drug Rights; Vertex Acquires ViaCyte; Merck & Orion Announces Collaboration; Verve Starts Trials of Cholesterol Drug; Kyowa Kirin Drops Nourianz follow-up KW-6356; FDA Orphan Drug and Fast Track Designations to CV-01
Byondis Files its HER2-Targeting Antibody-Drug Conjugate (ADC) Trastuzumab Duocarmazine in the US and Europe Byondis has filed for clearance of its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the United States and Europe, setting up a battle with heavyweight competitors Roche and Ast...
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Jun 28, 2022
Ipsen to Buy Epizyme; BioMarin’s Gene Therapy for Hemophilia; AbbVie’s Qulipta for Chronic Migraine; FDA Approves Breyanzi for R/R LBCL; NDA Filed for Elacestrant in ER+/HER2- Breast Cancer; EU Approval to Enhertu for Breast Cancer; FDA Approves Novartis’ BRAF-positive Tumor Combination; GSK’s Hepatitis B Vaccine, Bepirovirsen
Ipsen to Buy Biopharmaceutical Company Epizyme for USD 247 Million The restructuring of French manufacturer Ipsen has progressed with a takeover agreement for US competitor Epizyme and its cancer drug Tazverik in a deal for slightly less than USD 250 million. Ipsen is proposing USD 1.45 per share for Epizyme, va...
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May 24, 2022
PTC Therapeutics’ Gene Therapy Upstaza; Sanofi and Regeneron’s Dupixent; Bayer CAR-T Collaboration with Atara; FDA Accepts Biohaven’s Zavegepant; AbbVie Files FDA Approval for ABBV-951; Innoviva to Acquire Entasis; FDA Orphan Drug Designation to XMT-2056; FDA Approves Azacitidine for Juvenile Myelomonocytic Leukemia
EU Recommends Approval for PTC Therapeutics’ Gene Therapy Upstaza Upstaza, a gene therapy developed by PTC Therapeutics for patients with the genetic condition AADC deficiency, has been recommended for EU approval, putting another test of gene therapy's commercial prospects in the union. Upstaza (eladocagene exu...
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May 19, 2022
Check-Cap’s Pivotal Trial for C-Scan; Curebase and Flow Neuroscience’s tDCS Device; Brainlab Acquires Majority Share in medPhoton; GE Healthcare to Invest in Pulsenmore; Medtronic’s Drug-Eluting Coronary Stent System; Remedee’ Endorphin Stimulation Solution;
Check-Cap Initiated the US Pivotal Trial for C-Scan® On May 11, 2022, Check-Cap Ltd., a clinical-stage diagnostic company initiated the US pivotal trial for C-Scan® at Mayo Clinic in Rochester Minnesota. C-Scan is the first and only patient-friendly, preparation-free screening test to detect polyps before they m...
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May 17, 2022
BMS Sells NY Biologics Plant; FDA Approves Mitsubishi Tanabe’s Radicava, Love Pharma Acquires MicroDoz; Sandoz Launches Generic of Roche’s Esbriet; Pfizer to Acquire Biohaven Pharma; eureKARE’s Cell and Gene Therapy CDMO; Atamyo’s LGMD Gene Therapies; FDA approves Eli Lilly’s Type 2 Diabetes Treatment
Love Pharma Completes the Acquisition of MicroDoz Therapy LOVE Pharma Co. has announced the completion of its acquisition of MicroDoz Theraphy Inc. ("MicroDoz"). Love Pharma holds exclusive manufacturing, marketing, packaging, selling, and distribution licenses in Europe, the United Kingdom, and North America. U...
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