Regulatory Approvals21 May 2026
Revolution Medicines' RAS inhibitor demonstrated significant efficacy by doubling survival in a Phase 3 clinical trial for pancreatic cancer. This positive...
Regulatory Approvals21 May 2026
The FDA issued a warning letter to Chinese manufacturer Harbin Jixianglong Biotech for allegedly circumventing import restrictions on GLP-1 receptor agonist...
Regulatory Approvals21 May 2026
Roivant Sciences reported its financial results for the fourth quarter and fiscal year ended March 31, 2026, alongside a comprehensive business update. Key...
Regulatory Approvals21 May 2026
BioSyent Inc. announced that Health Canada has approved Thyconvi™ (levothyroxine sodium), establishing it as the first and only levothyroxine oral solution...
Regulatory Approvals21 May 2026
The FDA's long-awaited analysis of adverse events related to COVID-19 vaccines in children found no definitive link between the vaccines and pediatric deaths....
Regulatory Approvals21 May 2026
Amgen's autoimmune drug Tavneos has been linked to 20 deaths in Japan since its 2022 launch, primarily due to vanishing bile duct syndrome (VBS), a...
Regulatory Approvals21 May 2026
AstraZeneca has received FDA approval for Baxfendy (baxdrostat), an aldosterone synthase inhibitor, for the treatment of uncontrolled or treatment-resistant...
Regulatory Approvals18 May 2026
Aardvark Therapeutics' lead asset, ARD-101, for Prader-Willi syndrome, has been placed on a full clinical hold by the FDA due to cardiac concerns. This action...
Regulatory Approvals18 May 2026
The Supreme Court has preserved mail-order access to the abortion pill mifepristone, issuing an indefinite stay on a lower court's ruling that aimed to...
Regulatory Approvals18 May 2026
aTyr Pharma announced its Q1 2026 results and a corporate update, highlighting a clear path forward for efzofitimod in pulmonary sarcoidosis. Following a Type...
Regulatory Approvals18 May 2026
Plus Therapeutics announced its Q1 2026 financial results and provided business updates. Key highlights include completing an upsized public offering...
Regulatory Approvals18 May 2026
Tracy Beth Høeg, the interim director of the FDA's Center for Drug Evaluation and Research (CDER), is reportedly exiting the agency, just days after FDA...
Regulatory Approvals15 May 2026
Monopar Therapeutics announced its first quarter 2026 financial results and provided key business updates. The company is on track to submit a New Drug...
Regulatory Approvals15 May 2026
The FDA has granted accelerated approval to BeOne Medicines’ BCL2 inhibitor, sonrotoclax (brand name Beqalzi), for the treatment of relapsed or refractory...
Regulatory Approvals15 May 2026
Curanex Pharmaceuticals provided a first quarter 2026 business update, highlighting continued progress with its lead drug candidate, Phyto-N. The company is...
Regulatory Approvals15 May 2026
Kyowa Kirin announced on May 14, 2026, that the U.S. Food and Drug Administration (FDA) has approved a dosing update for CRYSVITA® (burosumab-twza) in adults...
Regulatory Approvals14 May 2026
Arbutus Biopharma reported strong first-quarter 2026 financial results, significantly boosted by a major litigation settlement. The company, along with its...
Regulatory Approvals14 May 2026
Aquestive Therapeutics reported its first quarter 2026 financial results, demonstrating increased revenue and a significantly reduced net loss. The company...
Regulatory Approvals12 May 2026
On May 11, 2026, the U.S. Food and Drug Administration announced it is soliciting public input on efforts to advance drug repurposing to address unmet medical...
Regulatory Approvals12 May 2026
aTyr Pharma announced its path forward for efzofitimod in pulmonary sarcoidosis after receiving official minutes from a Type C meeting with the U.S. Food and...
Regulatory Approvals11 May 2026
Sanofi has reportedly requested the FDA remove its type 1 diabetes drug, teplizumab (Tzield), from the Commissioner’s National Priority Review (CNPV) program....
Regulatory Approvals11 May 2026
The FDA has reversed its previous rejections of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals' cell therapy, Ebvallo, for Epstein-Barr virus-positive...
Regulatory Approvals11 May 2026
Lexicon Pharmaceuticals reported its first-quarter 2026 financial results and provided key clinical updates across its cardiometabolic pipeline. The company...
Regulatory Approvals07 May 2026
A single case of hepatic failure associated with Eli Lilly’s weight-loss pill Foundayo was reported in the FDA’s Adverse Event Reporting System (FAERS),...
Regulatory Approvals05 May 2026
Passage Bio is cutting approximately 75% of its workforce, impacting around 18 employees, to reduce operating expenses. This decision follows the FDA's...
Regulatory Approvals05 May 2026
Argenx is seeking to expand the label of its generalized myasthenia gravis (gMG) drug, Vyvgart, to include patients who are seronegative for acetylcholine...
Regulatory Approvals05 May 2026
The FDA has approved Veppanu (vepdegestrant), developed by Pfizer and Arvinas, as the first-ever PROTAC therapy for advanced or metastatic ER-positive,...
Regulatory Approvals05 May 2026
The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6-3 against the approval of AstraZeneca's oral SERD camizestrant for HER2-negative advanced breast...
Regulatory Approvals01 May 2026
UniQure announced plans to submit a marketing application for its gene therapy, AMT-130, in the U.K. later this year, following a positive meeting with U.K....
Regulatory Approvals01 May 2026
Nicox SA reported its full-year 2025 financial results, demonstrating a significant improvement with revenue reaching €16.8 million, up from €7.9 million in...
Regulatory Approvals01 May 2026
The U.S. Food and Drug Administration (FDA) has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, asserting there is no...
Regulatory Approvals01 May 2026
The U.S. Food and Drug Administration (FDA) has approved Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets for the...
Regulatory Approvals30 Apr 2026
Sanofi and Novartis have initiated the first-quarter earnings season, with both companies actively defending patents for their respective key drugs. Sanofi is...
Regulatory Approvals30 Apr 2026
The FDA has launched a new initiative for real-time clinical trials, enabling drug sponsors to transmit data immediately to the regulator via cloud technology....
Regulatory Approvals30 Apr 2026
The FDA has released briefing documents raising significant doubts about two AstraZeneca cancer drugs, camizestrant and Truqap, ahead of an advisory committee...
Regulatory Approvals29 Apr 2026
The FDA has renewed its call for Amgen to withdraw its autoimmune drug Tavneos from the market, alleging that study personnel manipulated data in the pivotal...
Regulatory Approvals28 Apr 2026
Intellia Therapeutics announced positive topline results from its Phase 3 HAELO study of lonvo-z, an in vivo CRISPR-based gene editing therapy for hereditary...
Regulatory Approvals28 Apr 2026
The FDA issued warning letters to UCSF Radiopharmaceutical Facility and Par Health, citing significant deficiencies in their environmental monitoring and...
Regulatory Approvals28 Apr 2026
Cell and gene therapy leaders are discussing ways to accelerate bespoke gene editing treatments for children, exemplified by Baby KJ Muldoon's successful...
Regulatory Approvals28 Apr 2026
MediPharm Labs Corp. welcomes the U.S. Department of Justice and DEA's final order rescheduling FDA-approved cannabis drug products and state-licensed medical...
