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China has recently released a new edition of the Good Clinical Practice for Drugs - a guideline designed to ensure the ethical and scientific conduct of clinical studies, aiming to enhance the nation's research ecosystem and support innovation in biotechnology. 15 June 2026
Biotechnology
M&A featured heavily last week, with Incyte announcing plans to buy Vega Therapeutics, a subsidiary of Star Therapeutics, for up to $2 billion. Then came UK pharma major GSK’s revelation of an agreement to acquire US firm Nuvalent for up to $10.6 billion. Also of note, US biotech Cartesian Therapeutics entered into a licensing deal with China’s WestGene Biopharma on CAR-T therapies for autoimmune diseases. Sweden’s Camurus was served another complete response letter (CRL) by the US Food and Drug Administration (FDA) on its filing for Oclaiz (CAM2029). 14 June 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval to French pharma major Sanofi’s Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes (T1D). 13 June 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and prednisone as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer. 13 June 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
US pharma giant Merck & Co, known as MSD outside of the USA and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA). 29 May 2026
Pharmaceutical
Beren Therapeutics announced that the US Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C (I-NPC). 29 May 2026
Biotechnology
UK-based Accord Healthcare has won a National Institute for Health and Care Excellence recommendation for Hetronifly (serplulimab) in untreated extensive-stage small cell lung cancer, opening routine NHS access in England and Wales for a disease where progress has been stubbornly slow. 29 May 2026
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the USA for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). 29 May 2026
Generics
The US Food and Drug Administration (FDA) yesterday published two final guidances for industry related to establishing bioequivalence. 29 May 2026
Biotechnology
Rhapsido (remibrutinib) is approved to treat chronic spontaneous urticaria (CSU). CSU affects the skin and is thought to be an autoimmune disease (when the immune system mistakenly attacks the body’s own cells, tissues and organs), Australia’s Therapeutic Goods Administration (TGA) announced today. 28 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) for Sanofi’s venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder. 28 May 2026
Biotechnology
The US Food and Drug Administration has approved US pharma AbbVie’s Decnupaz (pivekimab sunirine-pvzy) for adults with blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive blood cancer. 28 May 2026
Pharmaceutical
US biotech Ironwood Pharmaceuticals, which is developing and commercializing life changing therapies for people living with gastrointestinal (GI) and rare diseases, announced that the US Food and Drug Administration (FDA) has approved the use of Linzess (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC).
L 28 May 2026
Pharmaceutical
BridgeBio Pharma announced that the US Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) with priority review for oral BBP-418 to treat individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 28 May 2026
Biotechnology
US biotech Outlook Therapeutics has won a key appeal against the US Food and Drug Administration, giving Lytenava (bevacizumab-vikg) another chance in wet age-related macular degeneration after a run of regulatory setbacks. 27 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant. 27 May 2026
Pharmaceutical
The past week was led by a busy European Medicines Agency review cycle, with its human medicines committee backing eight new medicines and 18 indication extensions, including an oral tablet formulation for Wegovy. The US Food and Drug Administration also added a fresh oncology approval for Datroway in triple-negative breast cancer. 26 May 2026
Biotechnology
Danish CNS specialist Lundbeck has won South Korean marketing authorization for Vyepti (eptinezumab), adding another Asian market to the rollout of its fast-growing migraine prevention drug. 26 May 2026
Pharmaceutical
Cambridge, USA-based drug developer Agios Pharmaceuticals announced that the European Commission has granted marketing authorization for Pyrukynd (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia, with an orphan medicinal product designation. 26 May 2026
Biotechnology
On May 20, the provisional registration of AstraZeneca’s Andexxa (andexanet alfa) lapsed. This means Andexxa is no longer provisionally approved for use in Australia and has been removed from the Australian Register of Therapeutic Goods (ARTG). 26 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval for Gilead Sciences’ Hepcludex (bulevirtide-gmod) 8.5mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the USA, and sending the firm’s shares up 3% to $134.36 by close on Friday. 23 May 2026
Biotechnology
AstraZeneca and Daiichi Sankyo have secured US approval for Datroway (datopotamab deruxtecan-dlnk) as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor therapy. 22 May 2026
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) today announced recommendations for medicines approval at its May 2026 meeting. These are passed on for European Commission final decisions, that usually come within two or three months. 22 May 2026
Biotechnology
An Expert View from Boyang Wang, the founder and managing partner of Immortal Dragons, a purpose-driven longevity fund based in Singapore focused on advancing life-extension and rejuvenation biotechnology. 22 May 2026
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