02 Aug 2019 Momenta Pharmaceuticals Launches Phase 2/3 Trial of M281 for the Treatment of Warm Autoimmune Hemolytic Anemia and is Granted FDA Fast Track Designation
01 Aug 2019 Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma
31 Jul 2019 TCR2 Therapeutics Announces Partnership with the National Cancer Institute for Phase 1/2 Trial of TC-210
31 Jul 2019 GEMoaB Announces First Patient Dosed With the Affinity-Tailored T-Cell-adaptor GEM3PSCA in a Phase I Study in PSCA-positive Late-Stage Solid Tumors
31 Jul 2019 FDA Approves New Monotherapy Indication for Merck’s KEYTRUDA® (pembrolizumab)
31 Jul 2019 Alligator Bioscience regains global rights from Janssen to CD40 agonistic antibody, ADC-1013 (JNJ-64457107)
29 Jul 2019 Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC)
29 Jul 2019 European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma
28 Jul 2019 Kodiak Sciences Announces Positive Interim Data from Ongoing Phase 1b Clinical Study of KSI-301, a Novel Anti-VEGF Antibody Biopolymer Conjugate for Treatment of Wet AMD, Diabetic Eye Disease, and Retinal Vein Occlusion, at the American Society of Retina
26 Jul 2019 Theratechnologies Receives Positive Recommendation From the CHMP for Trogarzo® in the European Union
26 Jul 2019 Novartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindness
26 Jul 2019 Roche receives CHMP positive opinion for new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer
26 Jul 2019 CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer
26 Jul 2019 Janssen Receives CHMP Positive Opinion for Stelara® (ustekinumab) Recommending Approval for the Treatment of Moderately to Severely Active Ulcerative Colitis in the EU
26 Jul 2019 Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone for Treatment of Patients with Relapsed and Refractory Multiple Myeloma
25 Jul 2019 Bristol-Myers Squibb Provides Update on Part 2 of CheckMate -227
25 Jul 2019 Bristol-Myers Squibb Announces CheckMate -227 Part 1a Meets Co-Primary Endpoint of Overall Survival
24 Jul 2019 Jounce Therapeutics Announces Update on Strategic Collaboration with Celgene Corporation
24 Jul 2019 FDA Approves Samsung Bioepis' HADLIMA™ (adalimumab-bwwd)
24 Jul 2019 FDA Approves Pfizer’s Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions
23 Jul 2019 FibroGen Announces First Patient Dosed in ZEPHYRUS, a Phase 3 Clinical Trial of Pamrevlumab for the Treatment of Patients with Idiopathic Pulmonary Fibrosis
23 Jul 2019 Resolve Therapeutics Announces Completion of Enrollment for Phase 2a Study of RSLV-132 for the Treatment of Lupus
23 Jul 2019 IMFINZI® (durvalumab) US Label Updated With Overall Survival Data in Unresectable, Stage III Non-small Cell Lung Cancer
22 Jul 2019 Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease
22 Jul 2019 Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis

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