https://www.fiercepharma.com/ a feed of the latest articles on our website en https://www.fiercepharma.com/pharma/novartis-gains-full-fda-nod-fabhalta-kidney-disorder-igan The FDA has converted its accelerated approval for Novartis' Fabhalta into a full blessing to treat patients with immunoglobulin A nephropathy (IgAN). The drug is endorsed to slow kidney function decline in adults at risk of disease progression. Jul 17, 2026 11:02am Kevin Dunleavy https://www.fiercepharma.com/53e40431-339b-4667-8336-be56d46b85a2 https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026-h2 In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. Jul 1, 2026 1:33pm Angus Liu, Kevin Dunleavy, Fraiser Kansteiner https://www.fiercepharma.com/a6f8f591-bb07-4a55-b9ca-16ca7271358a https://www.fiercepharma.com/pharma/novo-alvotech-face-continued-fda-scrutiny-plants-tied-recent-fda-rejections From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with troubled regulatory histories. Jul 17, 2026 10:36am Fraiser Kansteiner https://www.fiercepharma.com/58b4a186-0d85-41bf-a9ae-a9e3ccad71be https://www.fiercepharma.com/pharma/oral-glp-1-tracker-launch-trajectories-lilly-foundayo-novo-wegovy-pill Fierce Pharma is launching the weekly Oral GLP-1 Tracker, leveraging analysts’ notes and IQVIA data to monitor prescription trends and shifting market shares as Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo vie to become the go-to oral weight-loss solution for millions. Apr 21, 2026 10:06am Angus Liu, Kevin Dunleavy, Fraiser Kansteiner https://www.fiercepharma.com/95fc1f29-4c60-4c4e-85a1-7e3739ee4672 https://www.fiercepharma.com/pharma/gsk-merck-adcs-trial-wins-az-15b-egfr-buy-biotechs-new-patent-tricks ADCs from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck and GSK, delivered positive phase 3 readouts. AstraZeneca reached out to its spinout Dizal for an EGFR lung cancer med. Biotechs are growing protective of their intellectual property and business intelligence. And more. Jul 17, 2026 9:25am Angus Liu https://www.fiercepharma.com/73baa195-b5a6-4311-b176-9bf4db5583a4 https://www.fiercepharma.com/marketing/foundation-medicine-launches-quality-first-initiative-stand-out-cancer-testing-market Foundation Medicine has started the “Quality First” initiative to create awareness of how “not all cancer biomarker tests are created equal.” Jul 17, 2026 3:42am Nick Paul Taylor https://www.fiercepharma.com/356dc021-fb2d-4d7a-aacd-38a0ff58067d https://www.fiercepharma.com/marketing/lights-camera-action-cg-life-spotlight-rare-disease-dedicated-film-festival CG Life and its rare disease awareness platform 24/364 will host a first-of-its-kind rare disease film festival in San Diego next March featuring documentaries exploring the lived experience of patients with rare diseases. Jul 16, 2026 5:10pm Zoey Becker https://www.fiercepharma.com/7d35d04d-cfc8-4a20-9581-3f8ae019c783 https://www.fiercepharma.com/manufacturing/huahai-poaches-quality-chief-hengrui-amid-fda-manufacturing-citations Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility. Jul 16, 2026 4:13pm Angus Liu https://www.fiercepharma.com/f28d4061-8d1c-4eb3-95c3-0cdb60e8d8bc https://www.fiercepharma.com/marketing/vanda-shifts-nereus-marketing-high-gear-schumacher-indycar-sponsorship Vanda Pharmaceuticals is sponsoring an IndyCar to fuel awareness of its motion sickness pill, Nereus. The biotech backed the No. 47 car to represent its end of the multi-decade wait for a prescription therapy. Jul 16, 2026 10:14am Nick Paul Taylor https://www.fiercepharma.com/ddc1de6d-d498-4087-ac62-5d54f6cfa412 https://www.fiercepharma.com/manufacturing/bipartisan-senate-bill-seeks-build-vigilance-around-foreign-companies-making-drugs-us A bipartisan bill reintroduced by three senators aims to increase transparency around foreign influence on the United States’ drug supplies, marking a potential first step to imposing restrictions. Jul 16, 2026 11:01am Angus Liu https://www.fiercepharma.com/6a91918c-9439-413d-a18f-e6d619ac82ae https://www.fiercepharma.com/pharma/merck-scores-fda-nod-lipfendra-becomes-first-oral-pcsk9-treatment The FDA has approved Merck's internally developed cholesterol-lowering treatment Lipfendra for adults with hypercholesterolemia, or high levels of "bad" cholesterol. The drug, which is the first oral PCSK9 inhibitor to reach the market, has been pegged with peak annual sales potential of $5 billion. Jul 16, 2026 8:30am Kevin Dunleavy https://www.fiercepharma.com/a1e17dc6-b088-470b-8094-cf7312d8ee7d https://www.fiercepharma.com/marketing/otters-bears-and-pharma-lions-inside-gileads-bronze-winning-cannes-spot Gilead Sciences Canada and The Local Collective worked up a bronze-winning campaign for HIV med Descovy featuring AI-generated animals. Jul 16, 2026 9:28am Zoey Becker https://www.fiercepharma.com/a7f5052c-bc0d-41c0-93fc-439844ab190f https://www.fiercepharma.com/pharma/merck-touts-keytruda-front-line-win-endometrial-cancer-subtype-pd-1-first Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer. Jul 15, 2026 2:42pm Angus Liu https://www.fiercepharma.com/e1df048a-f6ec-4ba8-bdbf-7e77b51d92ee https://www.fiercepharma.com/pharma/sanofi-opens-new-chapters-pfizers-modernas-mrna-patent-litigation-sagas As Pfizer and Moderna have tied off certain threads in their separate webs of mRNA patent litigation, Sanofi has opened a new front to challenge the companies’ blockbuster COVID-19 vaccines. Jul 15, 2026 3:11pm Fraiser Kansteiner https://www.fiercepharma.com/bb2521ad-7ee2-49eb-8abd-85adad904cdb https://www.fiercepharma.com/pharma/novo-gets-head-start-lilly-europe-ec-approval-wegovy-pill-0 The European Commission has granted marketing authorization for Novo Nordisk’s Wegovy pill for people with obesity or who are overweight. The approval comes as Novo’s weight-loss rival, Eli Lilly, awaits European clearance for its oral GLP-1 drug, Foundayo. Jul 15, 2026 3:07pm Kevin Dunleavy https://www.fiercepharma.com/cbd4c13f-e40f-4eec-b7db-dae68ea770f7 https://www.fiercepharma.com/pharma/no-patent-protection-stelara-no-problem-jj-tremfya-fills-void Johnson & Johnson reported its fifth straight quarter with revenue growth of at least 6%. This surge has come despite the loss of patent protection for Stelara. Compensating for the shortfall is Tremfya, which topped the $2 billion mark in sales in a quarter for the first time. Jul 15, 2026 11:10am Kevin Dunleavy https://www.fiercepharma.com/946df853-b7f7-4166-9793-11a294b4262a https://www.fiercepharma.com/pharma/buzzy-veradermics-shows-its-oral-minoxidil-can-tackle-female-pattern-hair-loss-too With a midstage peek at the data on Veradermics’ oral formulation of the molecule behind the ubiquitous hair regrowth treatment Rogaine, analysts are feeling increasingly confident that the company is a cut above the rest when it comes to the opportunity in the under-tapped market for female pattern hair loss. Jul 15, 2026 11:12am Fraiser Kansteiner https://www.fiercepharma.com/56ef095a-0c51-48d5-9d42-673ffb93b4e4 https://www.fiercepharma.com/pharma/kelun-scores-sac-tmt-win-first-line-nsclc-population-missing-merck-massive-phase-3-program The clinical blueprint for Merck & Co.’s prized TROP2-directed antibody-drug conjugate, sac-TMT, could add a missing piece thanks to a landmark achieved by its partner, Kelun-Biotech. Jul 15, 2026 9:51am Angus Liu https://www.fiercepharma.com/8c234fa0-0f8d-40cd-b3a6-fae27f0f8bdd https://www.fiercepharma.com/marketing/sanofi-teams-special-olympics-unified-football-world-raises-respiratory-health-awareness Two years after its central role in the Paris Olympics in France, Sanofi is back in its home country once again supporting sport. Jul 15, 2026 2:41am Ben Adams https://www.fiercepharma.com/f508d1f6-018c-408d-9ff6-bb6051f6dd60 https://www.fiercepharma.com/pharma/insilico-signs-cdmo-bora-25b-ai-drug-discovery-deal Generative AI specialist Insilico Medicine has teamed up with another biopharma company, this time CDMO Bora Pharmaceuticals. The collaboration could ultimately be worth $2.5 billion if milestones are reached. Jul 14, 2026 10:32pm Kevin Dunleavy https://www.fiercepharma.com/2d30bc75-cbd1-4ddd-85cd-4ef25754529d https://www.fiercepharma.com/pharma/fda-approval-its-breast-cancer-blockbuster-hopeful-celcuity-could-belong-hands-big-pharma The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard-of-care for patients with breast cancer. Jul 14, 2026 4:36pm Darren Incorvaia https://www.fiercepharma.com/4414a180-1449-450c-b19f-c42cc68b06f9 https://www.fiercepharma.com/partner-content/directors-note-what-expect-partnerships-sites-summit Senior Director Kate Woda breaks down what attendees can expect at the Partnerships with Sites Summit, happening Sept. 14, 2026 in Boston, MA. Jul 14, 2026 2:31pm Kate Woda https://www.fiercepharma.com/ba420da0-07da-4dd9-bd2d-14fa4e61f648 https://www.fiercepharma.com/ai-and-machine-learning/inside-agency-view-havas-so-authenticity-connection-and-pushing-back In the second of a new series of interviews with top executives from leading healthcare and comms agencies, Fierce Pharma Marketing sat down with London-based Havas SO’s managing director, Joanna Quade and Creative Director, Lucy Doolan. Jul 14, 2026 6:25am Ben Adams https://www.fiercepharma.com/eea3cf5d-ad84-4c17-a7bd-c1754914691f https://www.fiercepharma.com/pharma/huyabio-scores-opdivo-combo-milestone-skin-cancer-trial Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase inhibitor HBI-8000 has succeeded in combination with Bristol Myers Squibb’s Opdivo in a phase 3 trial of patients with advanced skin cancer. Jul 14, 2026 10:13am Kevin Dunleavy https://www.fiercepharma.com/6eac59e0-b88c-4ec0-9875-8448cb0362fc https://www.fiercepharma.com/pharma/cellares-recent-automated-cell-therapy-wins-have-opened-biotech-floodgates After speedrunning a series of major manufacturing milestones in the past year-and-a-half, the “biotech floodgates” have opened for Cellares, the automated cell therapy manufacturing specialist’s co-founder and CEO told Fierce Pharma Manufacturing.  Jul 13, 2026 7:17pm Fraiser Kansteiner https://www.fiercepharma.com/785062da-4a1c-4cd6-80c5-f6baf93c0d62