Medicus Pharma Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention

Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic ...

Supernus Celebrates Five-Year Anniversary of Qelbree® FDA Approval, Continuing to Deliver on Real-World Experience in ADHD

Qelbree remains the first novel, non-stimulant ADHD medication approved in over a decade and is the only ADHD treatment with serotonin (5-HT2C) ...
Cure Today

FDA Approves Revtorpyk for Advanced HR-Positive, HER2-Negative Breast Cancer

FDA approval covers PIK3CA–wild-type HR+/HER2− advanced breast cancer progressing after ≥1 metastatic endocrine line, positioning gedatolisib as a post-endocrine targeted option with fulvestrant ± ...

Celcuity Inc. (CELC) Discusses FDA Approval of REVTORPYK for Advanced HR+/HER2- Breast Cancer and Commercial Launch Plans Transcript

Discusses FDA Approval of REVTORPYK for Advanced HR+/HER2- Breast Cancer and Commercial Launch Plans July 14, 2026 5:30 PM ...

Pallone scrutinizes FDA staffing ahead of user fee negotiations

The top Democrat on the House Energy and Commerce Committee wants the Government Accountability Office to examine the impact ...
RAPS

This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
Morning Overview on MSN

Capivasertib won FDA approval for a hard-to-treat form of prostate cancer

Men diagnosed with metastatic prostate cancer that lacks the PTEN protein now have a targeted drug option for the first time.
GlobalData on MSN

FDA changes rare disease tune again as it clears path for Regenxbio’s gene therapy

With a regulatory route now in place, Regenxbio expects to meet with the FDA again in July, with a BLA resubmission to follow in Q3 2026.

Trust in the FDA is collapsing. It’s time to get really transparent about our food and our drugs

Patients with no other options are watching an agency turn on its own scientists — and the trust that took a century to build ...

Your AI Model Passed Validation But Your FDA Audit Didn't—Here's Why

A model may perform exceptionally well and still lack the evidence package necessary to support regulatory review.
Rutland Herald

Merck’s LIPFENDRA® (enlicitide) is the First and Only Once-Daily Oral PCSK9 Inhibitor Approved by the U.S. FDA to Reduce LDL-C in Adults with Hypercholesterolemia

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved LIPFENDRA ® (enlicitide) tablets 20 mg as an adjunct ...
JD Supra

New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority

On July 3, 2026, the Office of Information and Regulatory Affairs (OIRA) released the 2026 Unified Regulatory Agenda, providing additional details ...