FDA

Tarsus Pharmaceuticals has agreed to acquire Alkeus Pharmaceuticals for $450 million, centering the deal on gildeuretinol.

FDA has granted accelerated approval to Replimune's Tudriqev plus nivolumab for anti-PD-1-refractory unresectable advanced cutaneous melanoma.

In today's Pharmaceutical Executive Daily, an antitrust attorney weighs the legal risks of a hypothetical AstraZeneca-Bristol Myers Squibb merger, Eli Lilly beats Wall Street estimates on soaring Mounjaro and Zepbound sales and raises its full-year guidance, and the FDA approves Moderna's first mRNA-based flu vaccine for adults 50 and older.

FDA has approved Takeda's Orzeyful as the first oral orexin receptor 2 agonist for narcolepsy type 1 in adults.

The FDA has approved mFLUSIVA (mRNA-1010), Moderna's mRNA-based influenza vaccine, for use in adults 50 and older.

In today's Pharmaceutical Executive Daily, FDA's advisory committee votes in favor of Replimune's RP1 efficacy data in advanced melanoma, three clinical-stage biopharmaceutical companies file for IPOs spanning cardiovascular, immune, and metabolic disease, and a new analysis examines why two-thirds of pharmaceutical product launches fail to meet expectations.

FDA's advisory committee voted 10 to 3 that efficacy data from the Ignyte study is evaluable and clinically meaningful.

In today's Pharmaceutical Executive Daily, a commentary examines why fragmented software tooling causes scientific judgment to get lost across the biologics R&D pipeline, Replimune shares crash nearly 32 percent after FDA reviewers raise concerns about its melanoma therapy, and FDA approves Viatris's Gwyn Lo as a new once-weekly contraceptive patch.

An FDA advisory panel voted to recommend six of seven unapproved peptides for compounding access, raising concerns about its newly appointed members.

FDA has approved Viatris' Gwyn Lo as a once-weekly low-dose estrogen contraceptive patch, offering women with a BMI below 30 a non-invasive hormonal contraception option.

Replimune shares fell nearly 32% after FDA staff reviewers raised concerns that its lead melanoma therapy RP1 lacks clear evidence of systemic efficacy.

In today's Pharmaceutical Executive Daily, FDA approves Otsuka's Simtriyo as the first NDSRI treatment for ADHD, argenx agrees to acquire Forte Biosciences for approximately $2.2 billion, and an AbbVie neuroscience researcher discusses the shift from symptom management to disease modification in Parkinson's research.

FDA has approved Otsuka's Simtriyo as the first norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD.

In today's Pharmaceutical Executive Daily, an FDA advisory panel narrowly votes to recommend easing restrictions on four unapproved peptides, a supply chain expert discusses how China's export controls are exposing vulnerabilities in the U.S. pharmaceutical supply chain, and a pharmacy benefits executive lays out a business case for more targeted employer-based GLP-1 coverage.

An FDA advisory panel voted narrowly to recommend four unapproved peptides, BPC-157, KPV, TB-500, and MOTS-c.

In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.

FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and monkeypox virus in a single reaction.

In today's Pharmaceutical Executive Daily, Invivyd's chief scientific officer discusses a platform designed to predict future viral variants ahead of time, Bristol Myers Squibb expands its AI compute infrastructure with Nvidia to build what it calls the most powerful AI factory in life sciences, and FDA clears Consano Bio's IND for a non-opioid biologic targeting chronic sciatica.

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.

In today's Pharmaceutical Executive Daily, Steer Bio discusses its regenerative cell therapy platform for cancer-related lymphedema, FDA approves Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor for advanced breast cancer, and Insilico Medicine enters a strategic alliance with Bora Pharmaceuticals worth up to $2.5 billion.

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.