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Lilly's oral GLP-1 Foundayo (orforglipron) approved for weight loss, challenging market incumbents.
FDA approved Foundayo, the only oral GLP-1 pill that can be taken anytime without food or water restrictions. The highest dose showed an average weight loss of 27 pounds in the ATTAIN-1 trial.
Gilead terminates midstage HIV trial amid ongoing FDA clinical hold.
Gilead has cancelled one of its midstage HIV trials, a decision following the FDA's clinical hold placed on two of its next-gen HIV assets in June of last year.
Novo Nordisk's manufacturing woes lead to partner drug rejections and 400 layoffs.
Novo Nordisk is laying off ~400 employees at its Bloomington, IN factory after FDA rejections for drugs from three different partner companies were linked to manufacturing issues at the site.
Artivion gains FDA PMA for aortic stent graft, triggering buyout option for Endospan.
The Atlanta-based medtech company received pre-market approval (PMA) from the FDA for its aortic stent graft system.
FDA approves first-in-class IL-23 receptor antagonist Icotrokinra for psoriasis.
The FDA approved icotrokinra for moderate to severe plaque psoriasis in patients aged 12 and older.
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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
AstraZeneca's phase 3 trial for a successor to Strensiq, targeting a rare metabolic disease, failed to meet its primary endpoint. This result casts doubt on the company's plans to expand its market reach beyond the current patient population served by its existing drug.
AstraZeneca's phase 3 trial for a successor to Strensiq, targeting a rare metabolic disease, failed to meet its primary endpoint. This result casts doubt on the company's plans to expand its market reach beyond the current patient population served by its existing drug.
Teva Pharmaceutical announced US FDA approval for Ponlimsi, a biosimilar to Prolia. The company also had its biosimilar candidate applications for Xolair accepted by both the FDA and EMA.
Teva Pharmaceutical announced US FDA approval for Ponlimsi, a biosimilar to Prolia. The company also had its biosimilar candidate applications for Xolair accepted by both the FDA and EMA.
i-Lumen Scientific received FDA approval for an Investigational Device Exemption (IDE) to begin U.S. enrollment in its i-SIGHT2 clinical study for dry AMD. This approval expands the global trial to the United States, following the treatment of the first participant in the United Kingdom.
i-Lumen Scientific received FDA approval for an Investigational Device Exemption (IDE) to begin U.S. enrollment in its i-SIGHT2 clinical study for dry AMD. This approval expands the global trial to the United States, following the treatment of the first participant in the United Kingdom.
EMA Approval: Ogsiveo (SpringWorks Therapeutics Ireland Limited)
Active substance: nirogacestat hydrobromide | EC Decision: 23/09/2025 | Status: Authorised | Flags: Orphan | Area: Desmoid Tumors | Papers: Sustainable RP-UPLC analysis of Nirogacestat for desmoid tumors using quality-by (Green Chemistry Letters and Reviews 2025); Nirogacestat—the pathway to approva
Biogen has received FDA approval for a high-dose version of its drug Spinraza. This move aims to enhance its competitive standing in the spinal muscular atrophy (SMA) market. Spinraza was initially approved nearly a decade ago but has since faced competition from new market entrants.
Biogen has received FDA approval for a high-dose version of its drug Spinraza. This move aims to enhance its competitive standing in the spinal muscular atrophy (SMA) market. Spinraza was initially approved nearly a decade ago but has since faced competition from new market entrants.
Novo Nordisk has secured FDA approval for Awiqli injection 700 units/mL. This basal insulin is indicated for adults with type 2 diabetes.
Novo Nordisk has secured FDA approval for Awiqli injection 700 units/mL. This basal insulin is indicated for adults with type 2 diabetes.
Neurolief secured an additional $6 million investment following FDA approval of Proliv™Rx. This funding will accelerate the U.S. rollout of the at-home brain neuromodulation therapy for patients suffering from depression with an inadequate response to antidepressants.
Neurolief secured an additional $6 million investment following FDA approval of Proliv™Rx. This funding will accelerate the U.S. rollout of the at-home brain neuromodulation therapy for patients suffering from depression with an inadequate response to antidepressants.
Haemonetics Corporation received FDA approval for expanded labeling of its VASCADE MVP® XL Venous Vascular Closure System. This approval allows the system to be used with larger sheaths, specifically those employed in market-leading PFA and LAAC technologies.
Haemonetics Corporation received FDA approval for expanded labeling of its VASCADE MVP® XL Venous Vascular Closure System. This approval allows the system to be used with larger sheaths, specifically those employed in market-leading PFA and LAAC technologies.