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Approval · news · pharmadog

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News · Approval

650 stories

Jul 21, 26The FDA’s 505(b)(2) pathway is an underestimated engine of value creationbiospace

Jul 21, 26Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ reviewbiospace

Jul 21, 26Jupiter enters psychedelics space with $100M deal for PharmAla's MDMA drugfiercebiotech

Jul 21, 26Agios says adios to sickle cell program over lackluster phase 2 datafiercebiotech

Jul 20, 26Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelicsbiospace

Jul 20, 26FDA’s radical transparency policy for rejections runs into legal uncertaintybiospace

Jul 20, 26Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide makerbiopharma dive

Jul 20, 26Genetic medicine luminaries launch new center for personalized therapiesfiercebiotech

Jul 20, 26Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvalsbiospace

Jul 20, 26Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trialfiercebiotech

Jul 20, 26Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independencebiospace

Jul 20, 26How Kyverna rode CAR T’s autoimmune wave to the FDA’s doorbiospace

Jul 19, 26Latigo preps IPO to fund non-opioid pain drug rival to Vertex’s Journaxfiercebiotech

Jul 17, 26Celcuity got its cancer drug approved. Then its stock dippedendpoints

Jul 17, 26Quitting smoking is hard. A Medicare change may push doctors to give more helpstat

Jul 17, 26Jasper gets a lifeline in merger with immune drugmaker Kirabiopharma dive

Jul 17, 26FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterolfda press

Jul 17, 26India’s life sciences sector at turning point for innovation: Reportbiospace

Jul 17, 26How well are AI-discovered drugs faring in the clinic?biopharma dive

Jul 17, 26GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 failbiospace

Jul 17, 26Dimerix snaps up Mission’s stalled, phase 2-ready kidney disease candidate in $292M dealfiercebiotech

Jul 16, 26‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D winsfiercebiotech

Jul 16, 26FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturersbiospace

Jul 16, 26Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeoverbiospace

Jul 16, 26Merck wins first approval of a PCSK9 cholesterol pillbiopharma dive

Jul 16, 26Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitorbiospace

Jul 16, 26STAT+: Pharmalittle: We’re reading about Kalshi bets on clinical trials, a Merck cholesterol pill, and morestat

Jul 16, 26STAT+: FDA approves Merck’s oral PCSK9 drug, a firststat

Jul 16, 26Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immunobiospace

Jul 16, 26J&J sees Spravato sales surge as psychedelic competitors loombiospace

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