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Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Romvimza (vimseltinib) to treat adult patients with enosynovial giant cell tumor (TGCT) when it impacts movement or where surgery is not an option. 14 August 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. 14 August 2026
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abello today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended two sublingual immunotherapy tablets for the treatment of moderate to severe allergic rhinitis in children whose symptoms are not controlled by symptomatic treatments. 14 August 2026
Pharmaceutical
The US FDA's national priority voucher pilot has now run for more than a year. Announced in June 2025 as a way to cut drug review times to one or two months, it has produced 22 awards, nine approvals, one rejection, one sponsor asking to be removed, and a public hearing at which speakers asked whether the agency has the authority to run it at all. 14 August 2026
Pharmaceutical
The European Medicines Agency (EMA) has validated the marketing authorization application for PF-07307405, the six-valent Lyme disease vaccine candidate from US pharma major Pfizer and French vaccine specialist Valneva, and has begun its assessment. No human Lyme vaccine is approved anywhere at present. 14 August 2026
Biotechnology
A new survey reveals that US biotechnology companies focused on developing treatments for rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the USA. 13 August 2026
Biotechnology
China’s’ Akeso announced that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC). 13 August 2026
Pharmaceutical
Medicines regulators in major international markets have issued a mix of new approvals, safety communications, direct healthcare professional communications, a marketing authorization revocation, a product recall and procedural updates over the past 10 days. Weight management, dermatology, oncology and influenza vaccination account for most of the approval activity. 13 August 2026
Pharmaceutical
US pharma major Eli Lilly today escalated its continued fight to protect patients from the dangerous black market for its investigational obesity drug retatrutide, filing six new lawsuits against US entities selling black-market products in addition to having referred hundreds of bad actors to regulators and law enforcement worldwide. 12 August 2026
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized an extension to the indication for Bayer’s Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flushes, caused by adjuvant endocrine therapy (AET) related to breast cancer. 12 August 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted and granted priority review to a New Drug Application from San Diego-based Belite Bio for tinlarebant in Stargardt disease type 1, an inherited retinal disorder with no approved therapy anywhere. The agency has set a Prescription Drug User Fee Act target action date of February 12, 2027. 12 August 2026
Pharmaceutical
Privately-held German biopharma company Isotope Technologies Munich (ITM) revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 11 August 2026
Pharmaceutical
Donald Trump signed an executive order on Monday recommending that American children be routinely immunized against 11 diseases rather than the 18 covered by the US Centers for Disease Control and Prevention's (CDC) 2024 schedule, and that the combined measles, mumps and rubella (MMR) vaccine be split into three single-disease shots. 11 August 2026
Pharmaceutical
The Organization of Pharmaceutical Producers of India (OPPI) is intensifying its dialogue with policymakers to establish a Regulatory Data Protection (RDP) regime in India. 11 August 2026
Pharmaceutical
M&A news continued last week, with Curium announcing it is acquiring fellow US radiopharmaceutical company Lantheum for around $8 billion. A heavily financial results week included second quarter figures from US pharma giants Merck & Co and Pfizer. Also of note, the US Food and Drug Administration finally granted approval for Replimune’s Tudriqev for melanoma. 9 August 2026
Pharmaceutical
Japanese drug major Astellas Pharma has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval of fezolinetant, a NK3 receptor antagonist, for the treatment of vasomotor symptoms (VMS, also known as hot flushes and sweating) associated with menopause. 8 August 2026
Pharmaceutical
Chinese biopharma TransThera Sciences' Yochanra (tinengotinib) has been approved in China for adults with advanced, metastatic or unresectable cholangiocarcinoma harboring a fibroblast growth factor receptor2 (FGFR2) fusion or rearrangement who have previously received systemic therapy and FGFR inhibitor treatment. 7 August 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), an oncolytic immunotherapy from Woburn, Massachusetts-based biotech Replimune, closing out a regulatory saga that had twice ended in rejection. 7 August 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Rhapsido (remibrutinib) 25mg film-coated tablets for the treatment of adults with chronic spontaneous urticaria (CSU) whose symptoms are not adequately controlled by antihistamines. 7 August 2026
Pharmaceutical
The US Food and Drug Administration has approved Japanese pharma major Takeda’s Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. The company’s shares rose 3% to 5,425 yen on the news. 6 August 2026
Pharmaceutical
The European Medicines Agency’s (EMA) safety committee, PRAC, concluded evaluation of new data regarding potential risk of medicines at its June meeting. 12 June 2026
Pharmaceutical
Shares in Sweden based drug developer Camurus fell as much as 7% on Thursday, after the US Food and Drug Administration (FDA) rejected the company’s application for Oclaiz (octreotide; CAM2029) extended-release injection a treatment for acromegaly. 12 June 2026
Pharmaceutical
The European Medicines Agency (EMA) has released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. 12 June 2026
Generics
Hungary’s largest drugmaker Gedeon Richter and Indian generics firm Hetero Labs have announced the signing of a global collaboration agreement to jointly develop, register and commercialize semaglutide injection (a generic version of Ozempic). 11 June 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs). 11 June 2026
Pharmaceutical
China is confronting a rising oncology burden alongside the challenge of opioid-induced constipation (OIC), a common and debilitating side effect of opioid-based pain treatment. 11 June 2026
Pharmaceutical
The global branded drug industry has urged G7 leaders to put pharmaceutical innovation at the center of their economic agenda, in a pre-summit statement that also serves as a clear pitch for policies more favorable to the sector. 11 June 2026
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) has expanded its priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumer safety. 10 June 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review Japan’s largest drugmaker Takeda’s supplemental Biologics License Application (sBLA) for intravenous (IV) Entyvio vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease in pediatric patients aged 2 years and older. 10 June 2026
Pharmaceutical
US pharma major AbbVie has secured a recommendation from the UK’s National Institute for Health and Care Excellence for Aquipta (atogepant) as an acute treatment option for adults with migraine. 10 June 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory sandbox to examine how artificial intelligence (AI) could support medicines development and drug safety assessment. 9 June 2026
Pharmaceutical
European vaccine policy led a relatively quiet week for global medicines regulation, with the European Medicines Agency recommending that COVID-19 vaccines be updated to target the XFG variant for the 2026/2027 vaccination campaign. 9 June 2026
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) released a Fina; Evidence Report assessing the comparative clinical effectiveness and value of oveporexton (TAK-861), from Japan’s Takeda Pharmaceutical for narcolepsy type 1. 9 June 2026
Biotechnology
US pharma giant Pfizer today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. 8 June 2026
Biotechnology
The European Commission has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation. 8 June 2026
Pharmaceutical
Among licensing news of note last week, US drug developer Agios Pharma struck a deal with South Korea’s Oscotec for the latter’s cevidoplenib, a potential treatment for immune thrombocytopenia. US major AbbVie won European Commission approval for its migraine drug Aquipta. Travere Therapeutics licensed rights to civorebrutinib from China’s Everest Medicines, and Alnylam Pharmaceuticals entered into an AI collaboration with Inceptive Nucleics worth a potential $2 billion. 7 June 2026
Pharmaceutical
Chiesi Global Rare Diseases, a unit of privately-held Italian drugmaker Chiesi, announced that the European Commission (EC) has approved Lojuxta (lomitapide) capsules for use in children 5 years of age and older with homozygous familial hypercholesterolemia (HoFH), for use alongside diet and other lipid-lowering treatments, including LDL-apheresis where available. 6 June 2026
Biotechnology
US biotech Biogen has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for salanersen, its investigational antisense oligonucleotide for spinal muscular atrophy (SMA). 5 June 2026
Generics
The US Supreme Court has handed a unanimous win to British drugmaker Hikma in a closely watched generics patent case brought by Irish biopharma Amarin. 5 June 2026
Biotechnology
US drugmaker Gilead Sciences today announced that the UK’s National Institute for Health and Care Excellence (NICE) has approved Livdelzi (seladelpar) for the use on the National Health Service (NHS) in England within its marketing authorization as an option for treating primary biliary cholangitis (PBC). 4 June 2026
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