📁 All Events (13898 stories)
Roche's Enspryng achieved a phase 3 victory, demonstrating a 68% reduction in relapse risk for patients with the rare autoimmune disorder MOGAD. This positive outcome suggests that a first-of-its-kind FDA approval for the neuroinflammatory disease may be imminent.
Roche's Enspryng achieved a phase 3 victory, demonstrating a 68% reduction in relapse risk for patients with the rare autoimmune disorder MOGAD. This positive outcome suggests that a first-of-its-kind FDA approval for the neuroinflammatory disease may be imminent. | Endpoints: relapse_risk_reduction
relapse_risk_reduction68%
The FDA has approved a once-daily HIV pill from Merck. This approval allows Merck to enter the HIV treatment market.
The FDA has approved a once-daily HIV pill from Merck. This approval allows Merck to enter the HIV treatment market.
Marketing authorisations were granted in 2026.
Marketing authorisations were granted in 2026.
The FDA has approved a wearable device for the treatment of pancreatic cancer. This approval was published online in Nature Biotechnology on April 17, 2026.
The FDA has approved a wearable device for the treatment of pancreatic cancer. This approval was published online in Nature Biotechnology on April 17, 2026.
The US Food and Drug Administration (FDA) has approved insulin icodec-abae, marketed as Awiqli. This marks the first once-weekly basal insulin treatment option for adults with type 2 diabetes.
The US Food and Drug Administration (FDA) has approved insulin icodec-abae, marketed as Awiqli. This marks the first once-weekly basal insulin treatment option for adults with type 2 diabetes.
The US Food and Drug Administration (FDA) approved the oral GLP-1 receptor agonist orforglipron, marketed as Foundayo, for daily use in people with overweight or obesity. Unlike other oral GLP-1 drugs, orforglipron can be taken any time of day without food or water restrictions.
The US Food and Drug Administration (FDA) approved the oral GLP-1 receptor agonist orforglipron, marketed as Foundayo, for daily use in people with overweight or obesity. Unlike other oral GLP-1 drugs, orforglipron can be taken any time of day without food or water restrictions.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in stock value. Consequently, a securities class action lawsuit has been filed against the company and an executive. The lawsuit represents investors who acquired Gossamer securities between June 16, 2025, and February 20, 2026.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in stock value. Consequently, a securities class action lawsuit has been filed against the company and an executive. The lawsuit represents investors who acquired Gossamer securities between June 1
relapse_risk_reduction68%
Revolution Medicines announced positive Phase 3 results for its pancreatic cancer treatment. This win caused the company's buyout price to soar, despite a previously rumored $30 billion buyout offer no longer being active.
Revolution Medicines announced positive Phase 3 results for its pancreatic cancer treatment. This win caused the company's buyout price to soar, despite a previously rumored $30 billion buyout offer no longer being active.
relapse_risk_reduction68%
Travere's drug for a kidney disease received FDA approval. This approval occurred despite the clinical trial results indicating that the drug did not improve kidney function, which disappointed expectations.
Travere's drug for a kidney disease received FDA approval. This approval occurred despite the clinical trial results indicating that the drug did not improve kidney function, which disappointed expectations.
An opinion piece discusses the lack of access for an adult patient to a recently approved breakthrough drug for a rare disease. The author points out that adults are frequently overlooked in rare disease clinical trials and advocacy efforts.
An opinion piece discusses the lack of access for an adult patient to a recently approved breakthrough drug for a rare disease. The author points out that adults are frequently overlooked in rare disease clinical trials and advocacy efforts.
Travere Therapeutics has gained FDA approval for Filspari (sparsentan) to reduce proteinuria. The approval is for patients aged eight years and over with FSGS without nephrotic syndrome.
Travere Therapeutics has gained FDA approval for Filspari (sparsentan) to reduce proteinuria. The approval is for patients aged eight years and over with FSGS without nephrotic syndrome.
Apotex Corp., in partnership with Orbicular Pharmaceutical Technologies and Gland Pharma, announced FDA approval for the first generic Infuvite® Adult Injection. This approval includes 180-day Competitive Generic Therapy (CGT) exclusivity for the Pharmacy bulk package.
Apotex Corp., in partnership with Orbicular Pharmaceutical Technologies and Gland Pharma, announced FDA approval for the first generic Infuvite® Adult Injection. This approval includes 180-day Competitive Generic Therapy (CGT) exclusivity for the Pharmacy bulk package.
Replimune received a second complete response letter (CRL) for its cancer therapy, leading to multiple rounds of layoffs. This regulatory rejection raises existential questions about the company's future unless it can find a path forward.
Replimune received a second complete response letter (CRL) for its cancer therapy, leading to multiple rounds of layoffs. This regulatory rejection raises existential questions about the company's future unless it can find a path forward.
Ideaya Biosciences and Servier's eye cancer drug candidate met its primary endpoint in a phase 2/3 trial. This positive result paves the way for a filing for accelerated FDA approval in the second half of the year.
Ideaya Biosciences and Servier's eye cancer drug candidate met its primary endpoint in a phase 2/3 trial. This positive result paves the way for a filing for accelerated FDA approval in the second half of the year.
relapse_risk_reduction68%
Revolution announced positive Phase 3 results for its pancreatic cancer drug, which nearly doubled survival in a key trial. An analyst described the results as a "game changer" for the difficult-to-treat tumor.
Revolution announced positive Phase 3 results for its pancreatic cancer drug, which nearly doubled survival in a key trial. An analyst described the results as a "game changer" for the difficult-to-treat tumor.
relapse_risk_reduction68%
Eli Lilly's BTK inhibitor Jaypirca achieved its fourth positive phase 3 readout in chronic lymphocytic leukemia (CLL). This trial demonstrated fixed-duration power, marking an industry first for the drug in this indication.
Eli Lilly's BTK inhibitor Jaypirca achieved its fourth positive phase 3 readout in chronic lymphocytic leukemia (CLL). This trial demonstrated fixed-duration power, marking an industry first for the drug in this indication.
relapse_risk_reduction68%
Artivion, an Atlanta-based medtech, received pre-market approval (PMA) from the FDA for its aortic stent graft system. This regulatory clearance also triggered a buyout option for Endospan.
Artivion, an Atlanta-based medtech, received pre-market approval (PMA) from the FDA for its aortic stent graft system. This regulatory clearance also triggered a buyout option for Endospan.
The FDA has approved a GLP-1 pill for the treatment of obesity. This approval was reported by Nature Reviews Drug Discovery on April 2, 2026.
The FDA has approved a GLP-1 pill for the treatment of obesity. This approval was reported by Nature Reviews Drug Discovery on April 2, 2026.
Preliminary results from the ADARNAT pilot phase, a phase 3 multicentre trial, suggest that axillary radiotherapy (ART) without lymphadenectomy might safely replace axillary lymphadenectomy (ALND) in breast cancer patients with limited node disease. The trial, conducted across 23 Spanish hospitals, randomized 272 patients.
Preliminary results from the ADARNAT pilot phase, a phase 3 multicentre trial, suggest that axillary radiotherapy (ART) without lymphadenectomy might safely replace axillary lymphadenectomy (ALND) in breast cancer patients with limited node disease. The trial, conducted across 23 Spanish hospitals,
relapse_risk_reduction68%