Sweden-based biopharma Immedica revealed that lurbinectedin (Zepzelca) combined with atezolizumab has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) as first-line maintenance therapy for extensive-stage small cell lung cancer, moving the combination closer to becoming the first approved regimen to improve survival beyond checkpoint inhibitor monotherapy in this setting. The opinion is based on data from the Phase III IMfort

Study highlights novel multi-mechanistic immunotherapy combination in checkpoint-refractory disease Data expected to inform immune modulation, treatment sequencing, and durability of response across hard-to-treat tumors Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that data from an investigator-initiated Phase II trial conducted at Memorial Sloan Kettering Cancer Center will be presented at the American Association for Cancer Research (AACR) Annual Meeting

April 3, 2026 -- Cipla USA Inc. the wholly owned subsidiary of Cipla Limited(BSE: 500087) (NSE: CIPLA) (hereafter referred to as "Cipla") today announced final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Cipla's Nintedanib Capsules are the generic therapeutic equivalent of Ofev®, marketed by Boehringer Ingelheim. IPF is a

Fast Track Designation highlights potential of CTIM-76 to address unmet need for patients with PROC CTIM-76 Phase 1a trial ongoing, with interim data expected in June 2026 April 02, 2026 -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation to CTIM-76, a CLDN6

The KEYTRUDA regimen is the first and only PD-1 inhibitor-based treatment approved in the European Union for these patients Approval supported by data from the Phase 3 KEYNOTE-B96 trial in which the KEYTRUDA regimen demonstrated a statistically significant improvement in progression-free and overall survival compared to placebo plus paclitaxel, with or without bevacizumab Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab), in combi

Research published in Molecular Therapy Nucleic Acids demonstrates broad biodistribution and controlled PMP22 silencing, supporting advancement toward human trials Armatus Bio, a late-preclinical stage biotech innovator developing vectorized RNAi medicines in neuromuscular disorders, today announced the publication of foundational data in Molecular Therapy Nucleic Acids describing the safety and biodistribution impact of TVR110, a first-in-class and potential best-in-class vectorized microRNA i

Ray Therapeutics (RayTx), a clinical-stage biopharmaceutical company pioneering optogenetic therapies for those living with retinal degenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead candidate, RTx-015, for the treatment of retinitis pigmentosa (RP). "Receiving RMAT designation is a critical step as we move along the continuum of progress toward bringing hope to patients with a

Fast Track designation is one of the FDA’s expedited programs meant to facilitate development and expedite review of new drugs that have the potential to address an unmet medical need in the treatment of a serious or life-threatening condition April 01, 2026 -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced that the U.S. Food and Drug Administration

Novel Transdermal Curcumin Formulation Demonstrates Pain Reduction and Improved Quality of Life in Phase 1b Clinical Trial Study published in Frontiers in Pain Research reports significant reduction in knee pain with topical curcumin formulation April 1, 2026 -- Vascarta Inc. today announced the publication of results from a randomized, double-blind, placebo-controlled clinical trial evaluating VAS-101, the company's investigational topical/transdermal curcumin gel, for the treatment of knee pa

A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for A2B543, an autologous CAR T-cell therapy designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. Fast Track is a pro