⚡ Top Events Today
Lilly's oral GLP-1 Foundayo (orforglipron) approved for weight loss, challenging market leaders
FDA approved the once-daily pill, which can be taken without food or water restrictions. The highest dose led to an average weight loss of 27 pounds in the ATTAIN-1 trial.
AstraZeneca's Strensiq successor fails Phase 3 trial for rare metabolic disease
The Phase 3 trial failed to meet its primary endpoint, casting doubt on plans to expand its market reach.
Novo Nordisk lays off 400 at Indiana plant following multiple FDA rejections for client drugs
Layoffs follow FDA rejections for drugs from three different companies manufactured at the facility, citing manufacturing issues.
Gilead terminates mid-stage HIV trial amid ongoing FDA clinical hold
The company terminated a mid-stage HIV trial, with an FDA clinical hold on two of its next-gen HIV drugs remaining in place since last June.
Precision immunotherapy shows promise in sepsis, improving organ dysfunction in Phase 3 trial
The randomized clinical trial demonstrated that the therapy was associated with improved organ dysfunction by day 9 compared with placebo.
📁 All Events (13615 stories)
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.
AROA Biosurgery Limited announced the completion of its randomised controlled trial (RCT) for Symphony. A preliminary read-out indicates that the trial successfully achieved its primary endpoint.
AROA Biosurgery Limited announced the completion of its randomised controlled trial (RCT) for Symphony. A preliminary read-out indicates that the trial successfully achieved its primary endpoint.
Takeda has posted positive phase 3 data for an autoimmune asset targeting psoriasis, which it acquired for $4 billion. This data clears the path for a potential FDA submission, positioning Takeda to compete with companies like Bristol Myers Squibb and Johnson & Johnson for market share.
Takeda has posted positive phase 3 data for an autoimmune asset targeting psoriasis, which it acquired for $4 billion. This data clears the path for a potential FDA submission, positioning Takeda to compete with companies like Bristol Myers Squibb and Johnson & Johnson for market share.
Tanabe Pharma announced positive data from a Phase 3 trial of its oral drug for rare diseases causing pain upon light exposure. This represents the company's first major clinical milestone since its acquisition by Bain Capital.
Tanabe Pharma announced positive data from a Phase 3 trial of its oral drug for rare diseases causing pain upon light exposure. This represents the company's first major clinical milestone since its acquisition by Bain Capital.
Rocket received accelerated FDA approval for its hematopoietic stem cell-based gene therapy, Kresladi (marnetegragene autotemcel). This approval is for the treatment of certain children with severe leukocyte adhesion deficiency-1.
Rocket received accelerated FDA approval for its hematopoietic stem cell-based gene therapy, Kresladi (marnetegragene autotemcel). This approval is for the treatment of certain children with severe leukocyte adhesion deficiency-1.
Novocure reported positive clinical data for its electric field-based treatment in metastatic pancreatic cancer. This announcement follows an earlier FDA approval for the same treatment in local pancreatic cancer.
Novocure reported positive clinical data for its electric field-based treatment in metastatic pancreatic cancer. This announcement follows an earlier FDA approval for the same treatment in local pancreatic cancer.
The US FDA has approved the first generic version of fluticasone propionate inhalation aerosol, which is a generic equivalent to Flovent HFA. This approval is specifically for the maintenance treatment of asthma.
The US FDA has approved the first generic version of fluticasone propionate inhalation aerosol, which is a generic equivalent to Flovent HFA. This approval is specifically for the maintenance treatment of asthma.