FDA
Ousted: Makary Exits FDA; Sanofi Pulls Tzield
Makary's ouster leaves FDA with three acting leaders as Sanofi pulls diabetes drug Tzield from his signature priority review program.
FDA — Page 5
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
Lumryz Hits Phase 3 Win, Expansion Filing Next
Alkermes' Lumryz cleared a new Phase 3 in narcolepsy, putting the already-approved drug on a path toward a supplemental NDA filing.
FDA
Firing FDA Chief: Trump Plans Makary Ouster
WSJ reports Trump plans to fire FDA Commissioner Makary after 14 months marked by mass departures, a vaping feud, and warnings of political capture.
FDA
Firing: Trump to Oust FDA's Makary, 14 Months In
WSJ reports Trump plans to oust FDA Commissioner Makary after 14 months of unprecedented turnover and a White House battle over flavored vapes.
FDA
FDA Delays Leqembi SubQ Decision to August 24
FDA classified Biogen and Eisai's Leqembi SubQ initiation filing as a major amendment, moving the verdict from May 24 to August 24.
FDA
Viridian Soars 39% as Elegrobart Phase 3 Hits 54% PRR
Elegrobart's REVEAL-2 hit 54% PRR, vindicating Viridian after REVEAL-1 crashed shares 33% — and Q1 2027 filing is now on the table.
FDA
Cleared: Viridian Phase 3 as Wegovy Predictor Emerges
A blood test that predicts who responds to Wegovy could hand payers the tool they need to narrow GLP-1 coverage, and Viridian cleared Phase 3 again.
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
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…
