Regulatory

FDA has cleared Consano Bio's IND for C-1101, a platelet-derived biologic delivered via single epidural injection, enabling U.S. expansion of a Phase I trial targeting chronic sciatica.

FDA has converted Fabhalta's accelerated approval to a traditional approval for IgA nephropathy after confirmatory Phase III data showed the oral complement inhibitor slowed annual kidney function decline.

FDA has approved Merck's Lipfendra as the first oral PCSK9 inhibitor, giving patients with high LDL cholesterol a once-daily pill alternative to injectable therapies.

FDA has approved Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor, clearing it for HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation.

In today's Pharmaceutical Executive Daily, AstraZeneca acquires global rights to Dizal Pharmaceutical's lung cancer drug Zegfrovy in a deal worth up to $1.5 billion, FDA approves a subcutaneous formulation of Leqembi for early Alzheimer's disease, and a pharmacy executive weighs in on the education gap facing patients starting GLP-1 therapies.

FDA has approved a subcutaneous formulation of Leqembi, giving early Alzheimer's patients the option to self-administer the anti-amyloid therapy at home via weekly autoinjector.

FDA issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.

FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

FDA has approved Sarclisa Escena as the first anticancer treatment administered via an on-body injector, offering multiple myeloma patients and providers a subcutaneous alternative to time-intensive IV infusions across all three of isatuximab's existing indications.

AstraZeneca's Wainua failed to meet the primary endpoint of a late-stage trial in transthyretin-mediated amyloid cardiomyopathy, sending shares down nearly 10% in their largest single-day decline since late 2024.

This case could redefine the legal boundary between protecting pharmaceutical patents and allowing lower-cost generic drugs onto the market.

FDA has approved Accord BioPharma's Ennumo as a second pegfilgrastim biosimilar, giving the company what it claims is the world's largest G-CSF biosimilar portfolio from a single manufacture.

The Troutman Pepper Locke senior associate discusses strategies for pharma and biotech companies to implement ahead of the July 31st tariff deadlines.

Ryan Last, senior associate at Troutman Pepper Locke, details the key steps that pharma companies must make before the July 31st deadline hits.

A U.S. House committee has launched national security investigations into Merck, AbbVie, Eli Lilly, Pfizer, and Bristol Myers Squibb over their clinical trial operations in China, seeking answers by July 17 on data protection, military hospital ties, and trial sites in Xinjiang.

FDA selected seven companies to participate in its new PreCheck Pilot Program, offering earlier regulatory engagement and expedited facility review to incentivize domestic drug manufacturing.

The decision was made based on the results of the BRUIN CLL-313 clinical study.

Aprecia’s president and COO discusses the impact 3D printing technology is having on drug development, along with the benefits and challenges of being a company that is 100-percent US-based for its manufacturing.

The FDA has approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

In today's Pharmaceutical Executive Daily, the FDA announces Operation TrialBlazer, a pilot program aimed at cutting early-stage clinical trial timelines by six to 12 months as the US looks to reclaim its footing in global clinical research, market access expert Manasi Salgaonkar explains why Class of Trade classification is becoming one of the hardest — and most consequential — problems in pharmaceutical commercial operations, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on how DARPA's EQUIP-A-Pharma program is using federal investment to incentivize the reshoring of drug manufacturing to the United States.

FDA plans a pilot to shorten early-stage drug trial timelines, raising strategic questions for biopharma development and investment.

FDA advisory panel voted 9-0 to recommend approval of Moderna's mRNA flu vaccine mRNA-1010 across both the 50-to-64 and 65-and-older age groups, a unanimous outcome that validates the underlying clinical data.

FDA has expanded Capvaxive's indication to high-risk children and adolescents aged 2 through 17 who have completed a primary pneumococcal series, making it the only conjugate vaccine in the U.S. specifically studied and approved for this population.

FDA has approved Utebzi as the first oral carbapenem antibiotic for complicated urinary tract infections, giving patients and providers an alternative to intravenous-only carbapenem therapy.

Novavax’s EVP of corporate affairs and head of its Sweden division discusses new vaccine technologies, such as its adjuvant matrix technology, are bringing new players into the space.