FDA
Supreme Court Restores Mifepristone Mail Access
Mail-order mifepristone is back after the Supreme Court reversed an appeals stay, but the litigation that created the disruption is still running.
FDA — Page 2
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
ODAC Rejects AstraZeneca Camizestrant 6-3 After 9 Months
FDA ended nine adcomm-free months on April 30 with split votes on two AstraZeneca cancer drugs, but consultants warn it's a narrow restart.
FDA
FDA Clears Pfizer-Arvinas Veppanu as First PROTAC
FDA cleared Veppanu on Friday as the first-ever PROTAC therapy, a new drug class that actively degrades disease-causing proteins rather than just blocking them.
FDA
Celcuity Beats Piqray in Phase 3, Shares Jump 15%
Pfizer sold gedatolisib to Celcuity for $10 million upfront in 2021.
FDA
FDA Clears Arvinas' Veppanu, First PROTAC Drug
FDA cleared Veppanu (vepdegestrant) on Friday, a month ahead of its June 5 PDUFA date, making the Pfizer-Arvinas collaboration the first to take a PROTAC…
FDA
FDA Approves Axsome's Auvelity for Alzheimer's Agitation
FDA approved Axsome Therapeutics' Auvelity for agitation in Alzheimer's disease patients.
FDA
Moderna Pushes FDA on Covid Vaccine Access with Post-Marketing Data
Moderna told FDA it will provide post-marketing data on its Covid-19 vaccines to restore access to a broader population, the company confirmed May 1.
FDA
FDA Clears Auvelity for Alzheimer's, $2.1B Peak
FDA cleared Auvelity for agitation in patients with Alzheimer's dementia, making it the first non-antipsychotic drug cleared for this indication.
FDA
Fails CRC Trial: Krazati Approval at Risk for BMS
Bristol Myers Squibb's Krazati failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News.
FDA
FDA Panel Rejects AstraZeneca New Paradigm 6-3
FDA's oncology advisory committee voted 6-3 Thursday against AstraZeneca's late-stage trial for an oral drug candidate, voting down what the company had…
FDA
AbbVie Posts $15B Q1, Drops ABBV-101
AbbVie pulled in $15 billion in Q1 revenue, beating consensus estimates and raising its full-year guidance.
FDA
Lilly Strikes $11.5B in Three Deals as Regeneron Clears Otarmeni
Eli Lilly struck deals worth up to $11.55 billion across three acquisitions in two weeks: an up-to-$2.25 billion pact with AI biotech Profluent for genetic…
FDA
Posted $15.3B Q1, AstraZeneca Backs $80B 2030 Revenue Target
AstraZeneca posted $15.3 billion in first-quarter sales, led by Enhertu and Imfinzi, clearing the $14.7 billion analyst consensus and reinforcing CEO Pascal…
FDA
FDA Debuts Real-Time Clinical Trial Data Pilot
FDA is launching a pilot program to collect and review clinical trial data in real time, giving scientific reviewers direct access to trial results as they…
FDA
Boehringer-Zealand Obesity Drug Posts 13.4%, Trails Zepbound
Survodutide posted 13.4% placebo-controlled weight loss at 76 weeks in the SYNCHRONIZE-1 Phase 3 trial, solid enough to clear both primary endpoints, but…
FDA
Cleared 2 Phase 3 Trials, Incyte Plans Povorcitinib Vitiligo Filing
Incyte will file for FDA approval of povorcitinib, its oral JAK1 inhibitor pill, in nonsegmental vitiligo after the drug hit in both of its Phase 3 trials.
FDA
FDA Moves to Strip Amgen's $459M Tavneos Over Manipulated Data
FDA proposed to rescind the approval of Tavneos, Amgen's oral treatment for ANCA-associated vasculitis, after CDER concluded that data from the drug's…
FDA
Passed Phase 3: Rezzayo Puts CorMedix's $300M Melinta Buy to Work
Rezzayo passed phase 3.
FDA
Filed: Intellia lonvo-z BLA on 87% HAE Attack Data
Intellia Therapeutics filed a rolling biologics license application for lonvo-z Monday, backed by Phase 3 data showing an 87% reduction in hereditary…
FDA
Intellia Files FDA After Lonvo-z Cuts Attacks 87%
Intellia began a rolling FDA submission for lonvoguran ziclumeran (lonvo-z) Monday after phase 3 data showed a single infusion reduced hereditary angioedema…
