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Tags: FDA Talicia sNDA

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1	Ashley Gallagher, Associate Editor Pharmacy Times One of Cabra girls on GoggleboxIRL. Dublin City, Ireland televisionentertainment	FDA Grants Breakthrough Therapy Designation for Nipocalimab to Treat Sjögren Disease - 5 days ago FDA Grants Orphan Drug Designation to AISA-021 for Systemic Sclerosis - 2 months ago FDA Accepts Resubmitted NDA for AXS-07 for Acute Treatment of Migraine - 3 months ago FDA Accepts NDA and Priority Review Application for Vimseltinib in Tenosynovial Giant Cell Tumors - 3 months ago FDA Grants Orphan Drug Designation to PT217 for Neuroendocrine Carcinoma - 3 months ago FDA Accepts Supplemental New Drug Application for Adagrasib for Colorectal Cancer - 9 months ago
2	Ed Silverman STAT News Pharmalot columnist. Senior writer at STATnews. pharmaceutical industry	STAT+: Catalent tries to reassure customers about its deal with Novo Holdings - about 1 month ago STAT+: Pharmalittle: We’re reading about FDA rejecting MDMA; a nasal spray for allergic reactions, and more - 3 months ago STAT+: U.K. trade group scolds Novo, Novartis, Pfizer, and Otsuka for violating industry codes - 5 months ago STAT+: Pharmalittle: We’re reading about Sanders dogging Novo Nordisk, Teva patents, and more - 6 months ago STAT+: FDA agrees to review a rare disease drug that its developer was about to give up on - 8 months ago STAT+: Pharmalittle: We’re reading about a Novo Nordisk deal, a Regeneron setback, and more - 8 months ago STAT+: Pharmalittle: We’re reading about a failed schizophrenia drug trial, a Pfizer cancer drug, and more - 9 months ago STAT+: FDA gives a mixed response to a petition seeking greater clinical trial transparency - 9 months ago STAT+: Pharmalittle: We’re reading about a tossed PhRMA lawsuit, secrecy clauses, and more - 10 months ago STAT+: FDA is blasted by advocates for pursuing a deal with data provider that has ties to opioid makers - 11 months ago STAT+: Pharmalittle: Bluebird claims big insurer will cover its sickle cell therapy; House Republicans threaten to subpoena FDA commish - 12 months ago STAT+: In response to criticism, FDA publishes new database of wayward clinical trial sponsors - 12 months ago STAT+: Pharmalittle: Sanofi scraps rare-disease drug deal under FTC pressure; patients regain weight after stopping Lilly’s Zepbound - 12 months ago STAT+: Pharmalittle: U.K. approves world’s first CRISPR-based medicine; FDA to review pricey cancer drug lacking confirmatory data - about 1 year ago STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India - about 1 year ago STAT+: Pharmalittle: Sarepta Duchenne therapy misses primary endpoint; FDA holds panel for first CRISPR treatment for sickle cell - about 1 year ago STAT+: Pharmalittle: Sanofi plans to spin off its consumer health biz; EMA says no evidence GLP-1 drugs linked to thyroid cancer - about 1 year ago STAT+: Novartis claims Takeda is stonewalling efforts to review trade secrets taken by a former employee - about 1 year ago STAT+: Pharmalittle: Pharma likely to expand legal attacks on Medicare negotiations; CDC recommends rationing RSV drug - about 1 year ago STAT+: Pharmalittle: Pharma moves closer to a pricing deal with U.K.; FDA to review AstraZeneca request for self-administered flu vax - about 1 year ago STAT+: Pharmalittle: FDA panel lacks confidence in Amgen cancer drug data; weight loss drugs linked to rare stomach problems - about 1 year ago STAT+: Pharmalittle: FDA finds problems at Novo’s main U.S. factory; polarizing ALS drug heads for FDA scrutiny - about 1 year ago
3	Meagan Parrish Pharma Voice Senior editor @industrydive. Pharma world follower. Wisconsin, USA pharmaceuticalsjournalismparenting	An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped? - about 2 months ago After Vyvanse patent loss, Takeda’s neuroscience division looks to enter a new era - 6 months ago Five years after closing the Shire deal, Takeda is ready to harvest from its latest reinvention - 10 months ago
4	Brittany Trang STAT News Health care business reporter. PhD. Indie rock fan. health carebusiness reporting	STAT+: ‘Sarepta’s like a curse on me’: FDA commissioner dismisses controversy over Elevidys - 2 months ago STAT+: Tough road ahead for Bluebird Bio despite FDA approval for sickle cell therapy - 12 months ago
5	Joyce Frieden MedPage Today Washington editor at MedPage Today. Board member at AHCJ. Greater Washington, DC area Healthcare journalism	Is Medicare's Negotiated Drug Price List Worth Celebrating? Depends on Whom You Ask. - 3 months ago Five Companies Sign Agreement to Participate in National Health Data-Sharing Network - 12 months ago
6	MedPage Today Staff MedPage Today Explains healthcare complexities. Not endorsements. New York, New York Healthcare journalism	NIH Loses in Court; NSYNC Member's New Diagnosis; Chief Resident Dies at 32 - 4 months ago
7	Amy Baxter Pharma Voice Scientist, inventor, former pediatrician. Atlanta, Georgia pain relieftechnologyinnovation	Sage’s recent trial failure adds pressure to its two-drug Biogen collab - 4 months ago Takeda plots ‘unprecedented patient diversity’ for psoriasis drug that could compete with BMS - 8 months ago
8	Sophie Putka MedPage Today Enterprise, investigative writer. New York, USA enterprise journalisminvestigative journalism	Quantifying Alcohol's Death Risk; NDAs Hide Docs' Mistakes; H5N1 Pandemic Prep - 5 months ago
9	Meghana Keshavan STAT News Biotech nerd and writer @statnews. biotechwriting	ICER casts doubt on Sarepta’s DMD gene therapy - 7 months ago FDA chastens pet companies over antibiotics - 12 months ago Novartis is building a new radioligand plant in China - 12 months ago
10	Elise Reuter MedTech Dive Reporter @MedTechDive. Covers medical devices. medical technologydigital therapeutics	FDA grants de novo nod to AI tool for detecting sepsis - 8 months ago

Journalists covering sNDA