FDA and Drug Approval News
Approvals, rejections and trial results, the decisions behind the sharpest single-day moves.
This Biotech Wins a Big FDA Approval. Why Wall Street Is Shrugging.
Ionis Pharmaceuticals wins regulatory clearance for its quarterly injection, Zanvastro, in Alexander disease. Analysts are focused elsewhere.
Avalo Therapeutics: Phase 2 Validation Has Created An IL-1β Franchise
Seeking Alpha · 6h ago
IONS-0.07%
US FDA approves Ionis Pharma's therapy to treat rare brain disorder
Reuters · Sep 3
The U.S. FDA on Thursday approved Ionis Pharmaceuticals' therapy to treat a rare disease that affects the brain's white matter, making it the first treatment to get the nod for the genetic disorde...
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar
The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
This strategic engagement is designed to strengthen NeuroThera's U.S. market position, visibility among key U.S. federal stakeholders, reinforce the clinical and public ‑ health importance of advancin...
Altria sues US FDA, court records show
Reuters · Sep 2
Marlboro-maker Altria sued the U.S. Food and Drug Administration on Wednesday, court records show.
uniQure seeks US approval for Huntington's gene therapy after FDA reversal
Reuters · Sep 2
Dutch gene therapy developer uniQure said on Wednesday it had applied for U.S. approval of its experimental treatment for Huntington's disease after the FDA reversed its earlier position on the drug,...
This strategic engagement is designed to strengthen NeuroThera's U.S. market position, visibility among key U.S. federal stakeholders, reinforce the clinical and public ‑ health importance of advancin...
Venture Global tells Plaquemines Phase 2 buyers that LNG deliveries on schedule, source says
Reuters · Sep 1
U.S. LNG developer Venture Global has told customers of its Plaquemines Phase 2 export plant in Louisiana that it remains on track to begin delivering contracted cargoes on schedule at previously agr...
Insurers Are Pulling Back From GLP-1 Drugs. The FDA Just Handed Eli Lilly Its Best Weapon Yet
247WallSt · Sep 1
Employer coverage of GLP-1 drugs is collapsing heading into 2027, but the FDA just gave Eli Lilly a specific piece of ammunition that could change the conversation in payer meetings for at least one slice of that market.
George Town, British Virgin Islands, 1st September 2026, Chainwire The post Aster and World Liberty Financial Launch USD1 RWA Boost: Phase 1, Offering 125M $WLFI + 6.25M USD1 in Rewards appeared first on Finbold.
Toronto, Ontario, August 31, 2026 – TheNewswire – NeuroThera Labs Inc. (TSXV: NTLX) (the " Company " or " NeuroThera "), a clinical-stage pharmaceutical company and a subsidiary of SciSparc Ltd. (Nasd...
The FDA updated the April recall to specify which states received the more than 27,000 packages of potentially contaminated rice
Revolution Medicines: Strong Buy RASONQUE FDA Approval And Zoldonrasib PDAC Expansions
Seeking Alpha · Aug 31
UTHR-0.54%
U
United Therapeutics highlights new data supporting two FDA filings
Seeking Alpha · Aug 30
RVMD-0.40%
Revolution Medicines: RASONQUE's FDA Approval Portends A New Oncology Titan
Seeking Alpha · Aug 29
TAK-1.28%
US FDA approves Takeda, Protagonist's drug for rare blood cancerPTGX
Reuters · Aug 28
The U.S. Food and Drug Administration has approved a first-of-its-kind drug from Takeda Pharmaceutical and Protagonist Therapeutics to treat a rare blood cancer, the health regulator said o...
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.
The privately held vapor company said its updated vaping device, the Juul2, offers what it's calling a more consistent vapor and nicotine delivery experience, and is designed to compete effectively wi...
The U.S. Food and Drug Administration on Friday authorized the marketing of three new 'JUUL2' e-cigarette products, the latest in a series of approvals for nicotine products the agency says may offe...
FDA approved Gilead's new once-daily HIV pill for patients on complex regimens
Quartz · Aug 28
Bixlenvo combines two existing Gilead drugs into a single tablet for adults whose virus is suppressed but who can't use current one-pill options
US FDA approves Lilly's Mounjaro to reduce cardiovascular risk
Reuters · Aug 28
Eli Lilly said on Friday the U.S. FDA has approved its diabetes drug Mounjaro to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high ri...
Pfizer-backed Priovant wins FDA approval for lead asset
Seeking Alpha · Aug 28
GILD-0.15%
US FDA approves Gilead's once-daily combination pill for HIV treatment
Reuters · Aug 27
The U.S. Food and Drug Administration has approved Gilead Sciences' once daily oral combination pill for treatment of adults whose HIV has already been reduced to very low levels, the co...
FDA approves daily HIV pill from Gilead designed to simplify treatment for some patients
CNBC · Aug 27
The Food and Drug Administration approved a once-daily HIV pill from Gilead that could help simplify care for some patients whose virus is already under control but who remain on complicated treatment...
US FDA approves updated COVID vaccines for 2026-27 seasonNVAXPFE
Reuters · Aug 27
The U.S. Food and Drug Administration approved Moderna, Novavax-Sanofi and Pfizer-BioNTech's updated COVID vaccines, the companies said on Thursday, after an advisory panel recommended that the shot...
Moderna receives FDA approval for updated 2026-2027 COVID-19 vaccines
TheFly · Aug 27
MRNA-2.23%
Moderna Receives U.S. FDA Approval for Updated 2026-2027 COVID-19 Vaccines
Accesswire · Aug 27
ROIV+1.51%
US FDA approves Roivant-Priovant's skin and muscle disease drug
Reuters · Aug 27
The U.S. Food and Drug Administration said on Thursday it approved a treatment from Roivant and partner Priovant Therapeutics for a rare disease, making it the first oral drug for the condition a...
Abbott just scored a regulatory first in diabetes care that no rival has matched, yet the stock sits well below where it traded a year ago. The real question is what it will actually take to close that gap.
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
Medtronic Bravo CF capsule delivery device focus of FDA Early Alert
Seeking Alpha · Aug 27
ABBV-1.48%
AbbVie files for EMA approval of Skyrizi for Crohn’s disease treatment
Seeking Alpha · Aug 27
RVMD-0.40%
FDA approves Revolution Medicines' first targeted drug for advanced pancreatic cancer
Quartz · Aug 26
The drug, Rasonque, nearly doubled median overall survival compared with standard chemotherapy in a 500-patient trial
Revolution Medicines announces FDA approval of Rasonque in adults
TheFly · Aug 26
RVMD-0.40%
U.S. FDA Approves Revolution Medicines' RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer
GlobeNewsWire · Aug 26
RVMD-0.40%
Revolution Medicines Stock (RVMD) Boosted By FDA Pancreatic Cancer Approval
TipRanks · Aug 26
RVMD-0.40%
Revolution Medicines Wins FDA Approval for Pancreatic Cancer Pill. What It Means for the Stock.
Barrons · Aug 26
Daraxonrasib, the pill touted by a former member of Congress and cancer patient as a ‘miracle drug,' has been granted approval in patients with pancreatic adenocarcinoma.
The FDA approved a new drug from Revolution Medicines that promises to transform treatment of pancreatic cancers that kill many patients within a year of diagnosis
WSJ · Aug 26
The FDA approved a therapy from Revolution Medicines that slows a cancer that kills 7 of out 8 patients within five years.
Revolution Medicines gets FDA nod for targeted pancreatic cancer drug
Reuters · Aug 26
The U.S. Food and Drug Administration on Wednesday approved Revolution Medicines' targeted drug for adults with metastatic pancreatic cancer who have received prior treatment or cannot receive com...
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
GSK’s ViiV Healthcare announces FDA approval of Tivicay PD
TheFly · Aug 26
GSK-1.91%
GSK-owned ViiV wins FDA label expansion for HIV drug Tivicay for newborns
Seeking Alpha · Aug 26
FDA decisions produce the sharpest single-day moves
This page carries regulatory and clinical headlines: approvals and rejections, trial results by phase, breakthrough and orphan designations, safety reviews and label changes. Each headline shows the ticker of the company beside it with the day's price change, and the ticker opens the full page for that stock.
Regulatory decisions produce the sharpest single-day moves in the market, because the outcome is binary and the whole value of a small company can rest on it. That makes them the clearest example of a news-driven gap, which is what the episodic pivot scanner is built to find. Insider cluster covers the days before: several insiders buying the same stock at the same time, ahead of a decision the market is waiting for.
Each row shows the source and the time elapsed, and the summary opens in place without leaving the page.
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