Short answer · reviewed 16 Oct 2026 What USFDA pharma compliance means for a drug plant USFDA pharma compliance means manufacturing to the CGMP rules in 21 CFR Parts 210 and 211. A drug made without them is legally adulterated,…
Rhapsido (remibrutinib) in one screen Rhapsido is an oral Bruton’s tyrosine kinase (BTK) inhibitor approved by the US FDA on 30 September 2025 for chronic spontaneous urticaria (CSU) in adults who stay symptomatic on H1 antihistamines. It is the first…
Reviewed and updated: 12 August 2026. Regulatory status, indications and Indian commercial-availability status change frequently. Verify against the primary sources in the References before making any clinical, procurement or regulatory decision. In brief Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate…
For an Indian formulation plant, “USFDA approval roadmap” essentially means that both your facility and your products meet United States Food and Drug Administration requirements for quality, safety, and compliance with current Good Manufacturing Practice (cGMP) under 21 CFR Parts…
Live regulatory tracker · CDER novel approvals FDA New Drug List 2026: All 46 Novel Drug Approvals and Key Insights Every new molecular entity and new therapeutic biologic cleared by FDA’s Center for Drug Evaluation and Research in 2026, with…
Overview Wegovy (semaglutide) is a long‑acting GLP‑1 receptor agonist available as a once‑weekly subcutaneous injection and a once‑daily high‑dose oral tablet. It is approved to reduce major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight,…
Diabetes is a global epidemic – in 2022 about 14% of adults had the disease (up from 7% in 1990). It causes serious complications (heart attack, stroke, kidney failure) and over 2 million deaths each year. New therapies are urgently needed.…
Reviewed against primary sources on 25 August 2026 · Darshan Singh, 23 years in pharmaceutical QC, QA and drug regulatory affairs (LinkedIn) The short answer There is no single document called the FDA guidelines for purified water system operation. The…
MYQORZO (aficamten) represents a significant advancement in the management of obstructive hypertrophic cardiomyopathy (oHCM), a condition characterized by thickened heart muscle that obstructs blood flow out of the heart. Approved by the FDA in December 2025, it provides a targeted…
On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved Lerochol (lerodalcibep-liga), a novel third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor developed by LIB Therapeutics, Inc. Lerochol is approved as an adjunct to diet and exercise to…