Outlook Therapeutics Reports EMA's Validation of MAA for ONS-5010 to Treat Wet AMD

Published: Dec 23, 2022 | Tags: Outlook Therapeutics, ONS-5010, Lytenava, bevacizumab, wet age-related macular degeneration, Regulatory, EMA, MAA

BridgeBio Pharma Initiates P-III Study (CALIBRATE) of Encaleret for Autosomal Dominant Hypocalcemia Type 1

Published: Dec 23, 2022 | Tags: BridgeBio Pharma, Encaleret, Autosomal Dominant Hypocalcemia Type 1, Clinical Trial, P-III CALIBRATE Study

Genentech’s Lunsumio (mosunetuzumab-axgb) Receives the US FDA’s Approval for Relapsed or Refractory Follicular Lymphoma

Published: Dec 23, 2022 | Tags: Genentech, Lunsumio, mosunetuzumab-axgb, Follicular Lymphoma, Regulatory, US, FDA, Approval

Merck Signs a Research Collaboration and Commercial License Agreement with Mersana for Novel Antibody-Drug Conjugates

Published: Dec 23, 2022 | Tags: Merck, Mersana, Immunostimulatory, Antibody-Drug Conjugates, Immunosynthen STING-agonist platform, Biotech

Eli Lilly Expands its 2021 Agreement with ProQR Therapeutics for New Genetic Therapies

Published: Dec 23, 2022 | Tags: Eli Lilly, ProQr Therapeutics, New Genetic Therapies, Biotech, 2021, Axiomer technology

Merck Signs an Exclusive License and Collaboration Agreement with Kelun-Biotech for Seven Antibody-drug Conjugate Candidates

Published: Dec 23, 2022 | Tags: Merck, Antibody-drug Conjugate Candidates, Cancer, Biotech

CSL’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B

Published: Dec 22, 2022 | Tags: CSL, Hemgenix, etranacogene dezaparvovec-drlb, Hemophilia B, Regulatory, US, FDA, Approval

Abbott’s Freestyle Libre 3 Combine with Automated Insulin Delivery System Mylife Loop in Germany

Published: Dec 22, 2022 | Tags: Abbott, Freestyle Libre 3 Integrated, Insulin Delivery System Mylife Loop, Germany

Everest Medicines Licensing Partner Pfizer Reports the US FDA and EMA’s Acceptance of NDA and MAA for Etrasimod in Ulcerative Colitis

Published: Dec 22, 2022 | Tags: Everest Medicines, Pfizer, Etrasimod, Ulcerative Colitis, Regulatory, US, FDA, EMA

Mirati’s Krazati (adagrasib) Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Advanced KRAS-Mutated Colorectal Cancer

Published: Dec 22, 2022 | Tags: Mirati, Krazati, adagrasib, KRAS-Mutated Colorectal Cancer, Regulatory, US, FDA, Breakthrough Therapy Designation

Novan's EPI Health Entered into Exclusive License Agreement with Sato Pharma for Rhofade in Japan

Published: Dec 22, 2022 | Tags: EPI Health, Novan, Rhofade, Japan, Pharma

Jazz Pharmaceuticals Exercised its Option to Advance Zymeworks' Zanidatamab for Cancer Patients

Published: Dec 22, 2022 | Tags: Jazz Pharmaceutials, Zymeworks, Zanidatamab, Biliary Tract Cancers, Pharma

Sobi and ADC Therapeutics Zynlonta (loncastuximab tesirine) Receives EC’s Conditional Marketing Authorisation for Diffuse Large B-Cell Lymphoma

Published: Dec 21, 2022 | Tags: Sobi, ADC Therapeutics, Zynlonta, loncastuximab tesirine, Diffuse Large B-Cell Lymphoma, Regulatory, EC, Conditional Marketing Authorisation

Anzac Animal Health’s Zycosan Receives the US FDA’s Approval as First Injectable

Published: Dec 21, 2022 | Tags: Anzac Animal Health, Zycosan, pentosan polysulfate sodium injection, Equine Osteoarthritis, Regulatory, US, FDA, Approval

Altimmune Reports 24-Week (12-Week Extension) Trial Results of Pemvidutide for the Treatment of Non-Alcoholic Fatty Liver Disease

Published: Dec 21, 2022 | Tags: Altimmune, Pemvidutide, Non-Alcoholic Fatty Liver Disease, Clinical Trial,

Sosei Heptares Partner Pfizer Report the First Patient Dosing of PF-07081532 in the P-II Clinical Trial for the Treatment of Type 2 Diabetes and Obesity

Published: Dec 21, 2022 | Tags: Sosei Heptares, Pfizer, PF-07081532, Type 2 Diabetes, Obesity, Clinical Trial, P-II, Clinical Trial

Radius Health's Tymlos (abaloparatide) Receives the US FDA’s Approval for the Treatment of Osteoporosis

Published: Dec 21, 2022 | Tags: Radius Health, Tymlos, abaloparatide, Osteoporosis, Regulatory, US, FDA, Approval

Verona Pharma Reports P-III Trial (ENHANCE-1) Results of Ensifentrine for the Treatment of Chronic Obstructive Pulmonary Disease

Published: Dec 21, 2022 | Tags: Verona Pharma, Ensifentrine, Chronic Obstructive Pulmonary Disease, Clinical Trial, P-III, ENHANCE-1 Trial

Atara Biotherapeutics Ebvallo (tabelecleucel) Receives EC’s Approval for Epstein‑Barr Virus Positive Post‑Transplant Lymphoproliferative Disease

Published: Dec 20, 2022 | Tags: Atara Biotherapeutics, Ebvallo, tabelecleucel, Epstein‑Barr Virus Positive Post‑Transplant, Regulatory, EC, Approval

Abbott’s Eterna Spinal Cord Stimulation System Receives the US FDA’s Approval for the Treatment of Chronic Pain

Published: Dec 20, 2022 | Tags: Abbott, Eterna Spinal Cord Stimulation System, Chronic Pain, Regulatory, US, FDA, Approval

Takeda Reports P-III Trial (AURORA) Results of Maribavir for Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Patients

Published: Dec 20, 2022 | Tags: Takeda, Maribavir, Cytomegalovirus Infection, Hematopoietic Stem Cell Transplant, Clinical Trial, P-III, AURORA Trial

Catalyst to Acquire Commercial Rights of Eisai’s Fycompa (perampanel) CIII in the US

Published: Dec 20, 2022 | Tags: Catalyst, Eisai, Fycompa, perampanel CIII, epileptic disorders, neurological diseases, Pharma

Gilead and Arcus to Present P-II Study (ARC-7) Results of Domvanalimab for Non-Small Cell Lung Cancer at ASCO Plenary 2022

Published: Dec 20, 2022 | Tags: Gilead, Arcus, Domvanalimab, Non-Small Cell Lung Cancer, Clinical Trial, P-II, ARC-7 Study, ASCO, 2022

Sanofi Expands its 2016 Agreement with Innate Pharma for Natural Killer Cell Therapies in Oncology

Published: Dec 20, 2022 | Tags: Sanofi, Innate Pharma, Natural Killer Cell Therapies, Oncology, B7H3 ANKET, 2016, Biotech

Merck Entered into a Clinical Trial Collaboration with GenFleet Therapeutics to Initiate P-Ib/II Trial of GFH925 + Erbitux (cetuximab) for Non-Small cell lung cancer

Published: Dec 19, 2022 | Tags: Merck, GlenFeet Therapeutics, GFH925, Erbitux, cetuximab, Non-small cell lung cancer, Pharma

Dr. Reddy's Subsidiary Aurigene Stops Clinical Development of AUR-101 for the Treatment of Psoriasis

Published: Dec 19, 2022 | Tags: Dr Reddy, Aurigene, AUR-101, Psoriasis, Clinical Trial, P-IIb, INDUS-3 Trial,

Dr. Reddy's Laboratories Entered into a License and Distribution Agreement with CardiaCare to Commercialize Digital Neuromodulation Wearable for Non-invasive Atrial Fibrillation

Published: Dec 19, 2022 | Tags: Dr Reddy, CardiaCare, Digital Neuromodulation Wearable, Non-invasive Atrial Fibrillation, MedTech

Bionomics Reports P-II Study (PREVAIL) Results of BNC210 for the Treatment of Social Anxiety Disorder

Published: Dec 19, 2022 | Tags: Bionomics, BNC210, Social Anxiety Disorder, Clinical Trial, P-II, PREVAIL Study

AbbVie’s Vraylar (cariprazine) Receives the US FDA’s Approval as an Adjunctive Treatment for Major Depressive Disorder

Published: Dec 19, 2022 | Tags: AbbVie, Vraylar, cariprazine, Major Depressive Disorder, Regulatory, US, FDA, Approval

uniQure Receives EMA’s CHMP Positive Opinion of Etranacogene Dezaparvovec for the Treatment of Adults with Hemophilia B

Published: Dec 19, 2022 | Tags: uniQure, Etranacogene Dezaparvovec, Hemophilia B, Regulatory, EMA, CHMP

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