Pharmaceutical Executive Editorial Staff

BioMarin licenses long-acting Fabry enzyme replacement therapy HM15421/GC1134A, while Ferring agrees to acquire fertility biotech Gameto.

Astellas gains an option on Audax’s IL-12 antibody-cytokine fusion DAX-044, while EVERSANA acquires London-based health economics firm Estima Scientific.

Teva acquires BioXcel’s BXCL501, under FDA review for at-home agitation use; Rumi Therapeutics gains an option on Enthorin’s Fragile X PDE2 inhibitor.

Pfizer’s talazoparib-enzalutamide combination moves to earlier line in prostate cancer, with eligibility tied to genetic testing and immature survival data.

FDA approved an at-home induction option for risankizumab-rzaa in adults with moderate-to-severe Crohn's disease, based on the phase 3 AFFIRM trial.

The FDA approved GSK's bepirovirsen for adults with chronic hepatitis B on nucleoside therapy, based on phase 3 trials showing 19% functional cure.

FDA’s conditional approval of Jemperli (dostarlimab-gxly) rests on a single-arm phase 2 trial, with independent-review data still maturing.

The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.

AstraZeneca will pay insitro $40 million upfront to apply AI to target discovery in MASH and cardiomyopathies, with no candidates named yet.

The FDA approved Tecentriq plus chemotherapy for stage III dMMR colon cancer, Roche’s 12th US indication for the immunotherapy.

Tukysa adds a chemotherapy-free maintenance option for HER2-positive metastatic breast cancer; liver toxicity monitoring remains a key consideration.

From Lilly's blockbuster earnings to a first-of-its-kind narcolepsy approval, a new mRNA flu vaccine, and a potential mega-merger that would reshape the industry — here's what you need to know.

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

FDA approved Baxfendy for adults with uncontrolled hypertension, introducing a new drug class in a large and competitive market.

FDA expanded Enhertu (trastuzumab deruxtecan) use in early HER2-positive breast cancer based on phase 3 neoadjuvant and adjuvant trial data.

FDA granted Compass Pathways with a rolling review for COMP360, a proprietary formulation of synthetic psilocybin, in treatment-resistant depression.

Early clinical data from the CHORD trial supported accelerated approval of the first gene therapy targeting OTOF-related hearing loss under the FDA Commissioner’s National Priority Voucher program.

Advice for making your story pitch stand out in this treatment space—where clearly conveying the "why it matters" is essential.

Tips for turning transactional outreach into a trusted working relationship.

Pharm Exec’s latest sampling of notable biopharma brand approvals and launches all have unique stories to tell—from the winding journeys to innovative “firsts” to new momentum for milestones to come.

Leaders in areas such as drug discovery, clinical development and market access will meet to discuss AI, failing life expectancy, and a new generation of talent.

Elliott Yoo, Senior Media Strategist at epocrates, takes a closer look at the trends in CME consumption and what the future of medical education will be – from the priorities for physicians as they juggle learning with patient care, to what type of activities resonate most with prescribers.

The Maryland facility will create cell therapies for use in future cancer trials.

The $1.3 billion acquisition—which included two aqua manufacturing plants—expands Merck’s portfolio in the veterinary pharma space.

Study finds that individuals who took GLP-1 agonists for a long duration had a lower risk of going on to develop more severe forms of liver disease, including cirrhosis and liver cancer.

The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.

The expanded indication for Zynrelef now includes soft tissue and orthopedic surgical procedures.

Obecabtagene autoleucel is chimeric antigen receptor T-cell therapy under evaluation for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

The Osteoboost device has been shown to slow the loss of bone strength and density in postmenopausal women with osteopenia.

Today's FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.