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Gilead Gets FDA Approval for Once-Daily Single Tablet for HIV
Bixlenvo is a once-daily single tablet HIV treatment for virologically-suppressed adults. read more
ViiV Gets Green Light for Treatment for Infants Living with HIV
Available in tablets for oral use and oral suspension, Tivicay PD is the first of its kind available to pediatric patients. read more
Hovione Completes $46M+ Expansion of Portugal Tablet Manufacturing Center
The expansion creates commercial-scale batch tablet capacity by bringing spray drying and tableting to the same site. read more
FDA Approves RevMed Pancreatic Cancer RAS Inhibitor
The once daily tablets reduced the risk of death by 60% compared to chemotherapy. read more
Takeda Gets Japan Approval for Novel Narcolepsy Drug
Just weeks after getting the FDA green light, Japan’s Ministry of Health, Labor and Welfare has approved Takeda’s Ozeful tablets. read more
Lilly Launches Oral Weight Loss Drug in the UK
The drug is currently only available through private healthcare and not via the publicly-funded NHS. read more
Teva Gets Priority Review for First-in-Class Oral Tourette’s Therapy
If approved, the drug will be the first new treatment for pediatric patients with Tourette syndrome in 10 years. read more
Trump Nominates Dr. Heidi Overton to Lead FDA
If confirmed by the Senate, the White House domestic policy aide would replace former FDA chief Marty Makary. read more
BioMarin to Buy Alesta to Gain Potential First Oral Therapy for Hypophosphatasia
The first of its kind for hypophosphastasia, the orally-active drug is currently undergoing a phase 1/2a trial. read more
Oral Solid Dose Regulatory Approval Update
CDER has approved 33 novel drugs so far, almost half of which are oral solid dose formulations. read more
Definium Shares Positive Phase 3 Results for Psychedelic ODT in Generalized Anxiety
If approved, DT120 ODT could offer a treatment option that works through an entirely different mechanism than anything currently used in clinical practice. read more
BMS Gets First FDA Approval for Oral CELMoD in Multiple Myeloma
Zenbexus marks the arrival of a new treatment class. read more
Jazz to Buy Actio Biosciences, Expanding Rare Epilepsy Portfolio
The deal will give the company a potential first-in-class oral drug for rare form epilepsy. read more
Sionna Cuts Cystic Fibrosis Program After Trial Fail
The experimental small molecule failed to meet the key activity endpoint in a phase 2a trial. read more
Takeda Wins FDA Approval for Novel Narcolepsy Drug
The oral orexin receptor 2 agonist treats the orexin deficiency that leads to NT1. read more
Tarsus Pays $450M for Alkeus, Picking Up Phase 3 Stargardt Disease Drug
If approved, gildeuretinol will be the first FDA-approved therapy for the inherited retinal disease. read more
Lilly Cancer Drug Secures Second FDA Breakthrough Designation
A phase 1/2 study showed promising results in treating patients with advanced solid tumors. read more
Pfizer Looks to Expand Oral Alopecia Drug to Vitiligo
Already approved in alopecia, once-daily Litfulo improved facial and body vitiligo. read more
Supernus, Indivior Merge to Form CNS-Focused Company
The new CNS powerhouse offers 11 marketed drugs and projects $2.2B in annual revenue. read more
FDA Approves Fixed-Dose Tylenol-Naproxen Combo
The approval marks the first and only OTC, fixed-dose combo of acetaminophen and naproxen sodium. read more

May/June 2026

2026 Annual Buyer’s Guide
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