Apps

Ashley St. Clair says she rejected $40 million Musk NDA for docEntertainment — Sep 8, 2026

United Therapeutics and Denali Outline Pipeline Shifts at Morgan Stanley Conference — 4dBiotech firms Crescent Biopharma, Denali Therapeutics, Kyverna Therapeutics, and United Therapeutics outlined forthcoming data, new indications, and expansive commercial strategies at the Morgan Stanley Global Healthcare Conference, signaling a push into pulmonary fibrosis, CNS, and other large patient populations. Denali highlighted its Avlayah Transport Vehicle platform and CNS programs, while United Therapeutics outlined a four‑product strategy for IPF/PPF and planned NDA activities, underscoring continued innovation and manufacturing expansion across the sector.

Nicole Hardy Shifting focus to larger populations like pulmonary fibrosis makes sense for growth but competition will be fierce.

FDA Extends Exelixis Drug Review to March 2027 — Sep 11, 2026The FDA has extended Exelixis' NDA review for zanzalintinib in combination with atezolizumab/Tecentriq for metastatic colorectal cancer by three months, moving the action date to March 3, 2027 after updated safety and efficacy data were deemed a major amendment. The development of zanzalintinib as a next-generation cancer therapy continues, with the delay potentially impacting timelines for patients, investors, and partners awaiting a decision.

Nicole Hardy The FDA's move to examine the new safety data more closely makes sense, though it will likely delay any benefits for those counting on the combination therapy.

Pawar, Sule Meet Modi Amid NDA Merger Speculation — Jul 22, 2026Sharad Pawar and Supriya Sule met Prime Minister Modi amid ongoing NEET-UG protests and pressed for the government to address demands, while Sule denied reports of an NDA merger, even as discussions about a possible reunification of NCP factions with the NDA circulated and a decision window of 8-15 days was mentioned.

Ascelia Completes FDA Meeting on OrviglanceHealth — Sep 8, 2026Biopharma firms report a mix of regulatory progress: Ascelia Pharma advances its Orviglance NDA with an FDA Type A meeting held and minutes due in about 30 days, while AstraZeneca secures FDA approval for Etcamah (camizestrant) after an advisory panel opposed it earlier, signaling a potential shift in benefit-risk assessment. Ascletis Pharma launches a US Phase I trial for ASC36 obesity drug under an IND, highlighting ongoing development in metabolism therapies alongside expectations of further data and pricing implications for investors.

NDA Mangal Milan strengthens unity Monsoon Session unfoldsPolitics — Jul 21, 2026In the Monsoon Session of 2026, the NDA held a 'Mangal Milan' meeting to project unity as Prime Minister Modi highlighted national achievements, while the opening day saw repeated adjournments amid opposition protests over paper leaks, student issues, and Ram Mandir donation allegations. Opposition floor leaders plan strategy meetings as Parliament proceeds with key bills under a session running until August 13, with Modi also noted as the longest-serving elected PM as NDA partners prepare to pass a congratulatory motion.

Jaguar Health Reports Q2 2026 Financials — Aug 18, 2026Jaguar Health reported Q2 2026 results showing revenue of about $1.23 million and a net loss of $12.68 million, with six-month revenue of $21.5 million and a net loss of $3.83 million, while highlighting crofelemer data that reduced parenteral support by up to 48% in microvillus inclusion disease and outlining a NDA package targeted for end of 2026 and an NDA submission in Q2 2027. The company also announced an investor webcast for August 19, 2026 to review the quarter and corporate updates, and reiterated its focus on crofelemer for rare gastrointestinal disorders and related partnerships.

Telix completes BiPASS trial enrollment, aligns with FDA on NDA path — Sep 2, 2026Telix has completed enrollment of 350 patients in its Phase 3 BiPASS trial evaluating Ga-68 PSMA-PET plus MRI for pre-biopsy prostate cancer detection, with the aim of improving diagnostic accuracy and reducing unnecessary biopsies. The company also aligned with the FDA on a New Drug Application pathway that could support reimbursement and broaden patient access if approved, a development that sparked investor interest.

Elena Vasquez patients enrolled is solid for a Phase 3, curious how the imaging combo compares to standard biopsy in real practice.

Monopar Starts Rolling NDA for ALXN1840 Wilson Disease — Jul 22, 2026Monopar Therapeutics has begun a rolling submission of a New Drug Application with the FDA for ALXN1840 to treat Wilson disease, with the first completed sections already filed under a rolling NDA process. The first-in-class albumin tripartite complex activator carries Fast Track, Orphan Drug, and Rare Pediatric Disease designations and aims to become the first novel-mechanism therapy approved for Wilson disease in decades.

Bloomberg Say He’s Not Trying to ‘Hide’ Anything by Holding Former Employees to NDA’sReporting — Jan 15, 2020Former New York City Mayor Michael Bloomberg (D) was on ABC’s “The View” to talk about his presidential campaign when he was pressed on reports that he fostered a work environment at his company that made female…

Grant Lawsuit Against WWE McMahon Heads to ArbitrationSports — Jul 21, 2026The Janel Grant lawsuit against Vince McMahon and WWE is moving to private arbitration, with the court-ordered dismissal of the federal case with prejudice while preserving the parties’ right to pursue claims in arbitration. The move follows years of disputes over the NDA, alleged sexual abuse and trafficking, and means the public case ends but the fight continues behind closed doors through private arbitration.

Experimental pancreatic cancer drug now available in Nebraska — Jul 23, 2026Daraxonrasib, an investigational KRAS-targeting drug, has shown the potential to more than double survival in stage IV pancreatic cancer compared with chemotherapy and is being offered through expanded access programs at Nebraska Medicine, with Ben Sasse publicly discussing his positive response. The FDA has accepted an NDA for daraxonrasib based on phase 3 trial results showing significant improvements in overall survival, progression-free survival, and response rate, signaling a possible breakthrough though not yet FDA approved.

LB Pharmaceuticals accelerates Phase 3 NOVA-2 timeline across 25 U.S. sites, targets 1H 2027 topline — Jul 22, 2026LB Pharmaceuticals now expects topline results from the Phase 3 NOVA-2 trial of LB-102 in schizophrenia in the first half of 2027, ahead of prior guidance, with a planned pre-NDA FDA meeting in the second half of 2027. The company highlights faster enrollment across about 460 patients at 25 U.S. sites, possible open-label extension and ongoing Phase 2 studies in bipolar depression and major depressive disorder, plus a cash runway into 2029 to support multiple readouts.

PolyPid Secures $320M D-PLEX100 Deal in U.S., CanadaBusiness — Jul 21, 2026PolyPid inked an exclusive U.S. and Canada commercialization deal with Azurity for D-PLEX100 to prevent surgical site infections, unlocking $15 million upfront, another $15 million upon FDA NDA acceptance, and up to about $300 million in additional milestones, with royalties mid-teen to mid-twenties and a U.S. launch aimed for Q1 2027. The agreement follows positive Phase 3 SHIELD II results and FDA Breakthrough Therapy Designation, with PolyPid retaining non-U.S. rights and manufacturing while Azurity funds clinical development for potential label expansions.

Bloomberg Agrees to Release Three Women From NDAs After Increased PressureReporting — Feb 22, 2020Former New York City mayor Michael Bloomberg has announced that his company will release three women from non-disclosure agreements (NDAs). Bloomberg’s media and financial services company located the NDAs of the three…

House Advances $1.15 Trillion NDAA, Attaches SAVE America Act — Jul 21, 2026House Republicans pushed the $1.15 trillion National Defense Authorization Act toward final passage, framing it as a vehicle to rebuild the defense industrial base, secure supply chains, and advance President Trump’s defense and election priorities. They resolved a conservative standoff by attaching the SAVE America Act to the NDAA, while debates over issues such as transgender service, Ukraine funding, and other amendments continue as Democrats push back on related foreign policy matters.

House Votes Against Advancing NDAA Even With The SAVE America Act Attached — Jun 30, 2026The House of Representatives voted against a procedural vote that would allowed debate on attaching the Safeguard America Voter Eligibility (SAVE) America Act to the National Defense Authorization Act (NDAA) in a…

Bloomberg’s Girlfriend on NDAs: ‘It Was Thirty Years Ago. Get Over It’Reporting — Feb 25, 2020Presidential hopeful Michael Bloomberg’s (D) partner Diana Taylor defended his use of nondisclosure agreements (NDAs). Addressing the agreements, Taylor told CBS News, “In none of them was he accused of doing anything…

Leon Black sues House Oversight to block subpoenas in Epstein probe — Sep 3, 2026Billionaire Leon Black sued a U.S. House Oversight Committee to block subpoenas demanding NDAs and his deposition in the Epstein probe, arguing the order exceeds authority and intrudes on privacy; he skipped a scheduled deposition and calls the inquiry a fishing expedition, while the committee defends the probe as necessary to uncover mishandling and Epstein's network, leaving the possibility of contempt if he continues to refuse.

Marcus Bell Billions in wealth buys a lot of lawyers, but it doesn't make the questions about those Epstein payments go away.

56 rights groups urge Congress to drop provision deepening US-Israel military ties — Sep 3, 2026A coalition of 56 civil rights and advocacy groups urged Congress to scrap Section 219 of the 2027 NDAA, warning that deepening US-Israel military technology ties would be dangerous as US public opinion shifts against unconditional support for Israel amid the Gaza war. The debate comes as Netanyahu signaled a move to reduce reliance on US military aid within about a decade and some lawmakers have already attempted to block the aid provision as the 3.8 billion annual assistance nears its 2028 expiry.

Nicole Hardy If Israel wants to reduce reliance on our money within a decade, seems like a good moment to actually renegotiate these terms.

Adam Sandler Officiated Kelce-Swift MSG Wedding — Aug 7, 2026Taylor Swift and Travis Kelce officially wed on July 3, 2026, at Madison Square Garden with about 1,000 guests, including Swift’s Eras Tour dancers who attended in black-tie attire and were part of a tightly managed guest experience overseen by NDAs. The ceremony, officiated by Adam Sandler, highlighted close family ties and featured dancer Kam Saunders, who described the day as remarkable and transformative while sharing glimpses of the fashion moments leading up to and after the wedding.

Biology Matters: Four Republicans Betray Military Readiness — Jul 25, 2026On July 21, four House Republicans chose political theater and identity ideology over those fundamentals, joining every Democrat to defeat Rep. Lauren Boebert’s amendment to the National Defense Authorization Act (NDAA) that would have codified President Donald Trump’s January 2025 executive order barring transgender-identifying individuals from military service.

Lauren Boebert Reveals Why She Missed Big NDAA Vote — Jul 23, 2026Republican Colorado Rep. Lauren Boebert claimed Wednesday that the vote on a bill for $1.1 trillion for military funding closed while she was waiting to talk to Department of War Secretary Pete Hegseth.

America’s Near-Trillion Dollar Defense Bill Adds Multiple Provisions Aimed Squarely At Hegseth’s Pentagon — Dec 12, 2025The new version of Congress’s near-trillion dollar defense budget bill includes multiple provisions aimed squarely at reigning in War Secretary Pete Hegseth’s Pentagon. The National Defense Authorization Act (NDAA) for…