⚡ Top Events Today
Revolution's pancreatic cancer drug nearly doubles survival in 'game-changer' Phase 3 trial.
The drug nearly doubled survival in a pivotal Phase 3 trial, with an analyst describing the results as a 'game changer'.
Travere secures controversial FDA approval for Filspari in FSGS despite missing kidney function endpoint.
Received FDA approval to reduce proteinuria in patients with FSGS, despite the clinical trial not demonstrating a statistically significant improvement in kidney function (eGFR slope).
Replimune receives second CRL for cancer therapy, leading to layoffs and raising existential questions.
The company received a second Complete Response Letter (CRL) from the FDA for its lead cancer therapy, prompting multiple rounds of layoffs.
Eli Lilly's Jaypirca scores fourth positive Phase 3 readout in CLL, demonstrating fixed-duration power.
Achieved its primary endpoint in a fourth Phase 3 trial, demonstrating efficacy as a fixed-duration treatment, an industry first for the drug in this indication.
Ideaya and Servier's eye cancer drug meets primary endpoint, paving way for accelerated approval filing.
The drug candidate met its primary endpoint in a pivotal Phase 2/3 trial, with plans to file for accelerated FDA approval in the second half of the year.
📁 All Events (13801 stories)
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.
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.
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.
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,
The US Food and Drug Administration (FDA) recently approved a first-of-its-kind device. This device is intended for adult patients with locally advanced pancreatic cancer.
The US Food and Drug Administration (FDA) recently approved a first-of-its-kind device. This device is intended for adult patients with locally advanced pancreatic cancer.
The US Food and Drug Administration (FDA) approved icotrokinra, a first-in-class interleukin-23 receptor antagonist. It is indicated for the treatment of moderate to severe plaque psoriasis in patients aged 12 years or older.
The US Food and Drug Administration (FDA) approved icotrokinra, a first-in-class interleukin-23 receptor antagonist. It is indicated for the treatment of moderate to severe plaque psoriasis in patients aged 12 years or older.
A randomized trial demonstrated that iFR-guided coronary artery bypass grafting (CABG) significantly improved LIMA-to-LAD artery graft patency (80.5% vs. 56.8%) and saphenous vein graft patency (90.2% vs. 70.3%) at 36 months compared to angiography-guided CABG. Major adverse cardiac and cerebrovascular events were similar between the groups.
A randomized trial demonstrated that iFR-guided coronary artery bypass grafting (CABG) significantly improved LIMA-to-LAD artery graft patency (80.5% vs. 56.8%) and saphenous vein graft patency (90.2% vs. 70.3%) at 36 months compared to angiography-guided CABG. Major adverse cardiac and cerebrovascu
Gilead Sciences has terminated one of its midstage HIV trials. This action follows the FDA's decision last June to place two of Gilead's next-gen HIV drugs on clinical hold, which remains intact.
Gilead Sciences has terminated one of its midstage HIV trials. This action follows the FDA's decision last June to place two of Gilead's next-gen HIV drugs on clinical hold, which remains intact.
Novo Nordisk is laying off approximately 400 employees at its Bloomington, IN factory. This decision follows FDA rejections of drugs from three different companies that had contracted with the facility, citing manufacturing issues.
Novo Nordisk is laying off approximately 400 employees at its Bloomington, IN factory. This decision follows FDA rejections of drugs from three different companies that had contracted with the facility, citing manufacturing issues.
The U.S. Food and Drug Administration (FDA) has approved Foundayo (orforglipron). This approval is the fifth under the Commissioner's National Priority Voucher (CNPV) pilot program.
The U.S. Food and Drug Administration (FDA) has approved Foundayo (orforglipron). This approval is the fifth under the Commissioner's National Priority Voucher (CNPV) pilot program.
The FDA has approved Lilly's Foundayo (orforglipron), a GLP-1 pill for weight loss. It is notable for being the only GLP-1 pill that can be taken any time of day without food or water restrictions. In the ATTAIN-1 clinical trial, adults on the highest dose lost an average of 27 pounds.
The FDA has approved Lilly's Foundayo (orforglipron), a GLP-1 pill for weight loss. It is notable for being the only GLP-1 pill that can be taken any time of day without food or water restrictions. In the ATTAIN-1 clinical trial, adults on the highest dose lost an average of 27 pounds. | Endpoints:
The ImmunoSep randomized clinical trial (RCT) assessed precision immunotherapy in patients with sepsis. The trial demonstrated that precision immunotherapy was associated with improved organ dysfunction by day 9 compared with placebo.
The ImmunoSep randomized clinical trial (RCT) assessed precision immunotherapy in patients with sepsis. The trial demonstrated that precision immunotherapy was associated with improved organ dysfunction by day 9 compared with placebo. | Endpoints: Organ Dysfunction by Day 9: improved vs placebo