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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
Biotechnology
The US Food and Drug Administration (FDA) has accepted Merck & Co's supplemental Biologics License Application (sBLA) for its respiratory syncytial virus (RSV) antibody Enflonsia (clesrovimab-cfor), seeking to expand its indication to children under two years old at increased risk of severe RSV disease through their second RSV season. 6 August 2026
Biotechnology
Cambridge, USA-based mRNA vaccines company Moderna announced that the US Food and Drug Administration (FDA) has approved mFlusiva (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older. 6 August 2026
Pharmaceutical
Boston, USA-based clinical-stage biotech CervoMed shares jumped 7.7% to $2.80 yesterday, after it announced that its investigational drug candidate, neflamapimod, has received an Innovation Passport designation to enter the UK’s Innovative Medicines and Health Products Regulatory Agency (MHRA) Accelerated Access Pathway (ILAP) for the development of neflamapimod in dementia with Lewy bodies (DLB). 5 August 2026
Pharmaceutical
NHS England has recommended Procysbi (mercaptamine bitartrate [cysteamine] gastro-resistant hard capsules), also referred to as "delayed-release mercaptamine bitartrate", for routine commissioning for eligible patients aged one year and above with nephropathic cystinosis, family-controlled Italian drugmaker Chiesi revealed today. 5 August 2026
Biotechnology
Swiss-domiciled oncology company BeOne Medicines has been awarded an Innovation Passport by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for BGB-B2033, an experimental bispecific antibody for hepatocellular carcinoma, the most common form of primary liver cancer. 4 August 2026
Pharmaceutical
Sanofi today announced that the European Commission (EC) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age. 4 August 2026
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim (BI) has recently secured European marketing authorization for Jascayd (nerandomilast) for the treatment of both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). 4 August 2026
Pharmaceutical
Today, the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) released a new issue brief on the health and economic impact of vaccines and the importance of maintaining access to vaccination. 3 August 2026
Pharmaceutical
Australia is the latest country to undertake a review of the benefits and risks of Tavneos (avacopan), the regulator Therapeutic Goods Administration (TGA) announced today. 3 August 2026
Pharmaceutical
The UK’s Prescription Medicines Code of Practice Authority (PMCPA) has today launched a public consultation on proposed amendments to its constitution and procedure. 3 August 2026
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the final design of the Expedited Investigational New Drug (IND) Pilot. Accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation is a core priority for the Trump Administration. 16 September 2026
Biotechnology
Danish CNS specialist Lundbeck today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for Vyepti (eptinezumab) for the prevention of migraine attacks in adults, marking an important milestone for patients in Japan and for Lundbeck's continued growth in Asia. 16 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved an additional warning in labeling for Kybella (deoxycholic acid) injection regarding adverse reactions associated with use of the drug outside of the submental fat region (fat under the chin, known as a “double chin”) and recommends against this unapproved use. 16 September 2026
Pharmaceutical
When patients are waiting for new treatments, safety and speed both matter, according to trade group Pharmaceutical Research Manufacturers of America (PhRMA). 16 September 2026
Pharmaceutical
Medicine shortages have shifted over the past two years from a problem managed in hospital pharmacies to a matter of industrial and trade policy on both sides of the Atlantic. Active shortages in the USA peaked in early 2024 and have since fallen, while Europe has built a list of critical medicines, a reporting platform and, in May 2026, a provisional deal on its Critical Medicines Act. 16 September 2026
Pharmaceutical
An Expert View from Mike D’Ambrosio, Senior Vice President and Global Head, Real World Research, Parexel, and Tala Fakhouri, Ph.D., M.P.H., Chief AI and Regulatory Strategy Officer, Parexel. 16 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Revolution Medicines Rasonque (daraxonrasib), the company’s RAS(ON) multi-selective inhibitor, for treatment-naïve metastatic pancreatic adenocarcinoma (PDAC) in combination with gemcitabine and nab-paclitaxel (GnP), a multiagent chemotherapy regimen widely used in treating patients with PDAC. 15 September 2026
Pharmaceutical
France-headquartered radiopharmaceutical company, Curium, has won US Food and Drug Administration (FDA) approval for Bexlutry (lutetium Lu 177 dotatate injection), its first radioligand therapy to reach the US market, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 15 September 2026
Pharmaceutical
Germany-based Biofrontera has announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, for the treatment of superficial basal cell carcinoma (sBCC) in adults. 15 September 2026
Pharmaceutical
Real-world data is the information generated when patients are treated in ordinary practice rather than in a clinical trial: hospital and family doctor records, insurance claims, disease registries and, increasingly, readings from wearable devices. Real-world evidence is what emerges when that information is analyzed to answer a question about how a medicine performs in use. 15 September 2026
Pharmaceutical
Medicines regulators in major markets issued a run of cancer and rare-disease approvals, product recalls and safety communications over the past week, with activity concentrated in North America and Australia. 15 September 2026
Pharmaceutical
UK pharma major GSK is preparing to ask US regulators to widen the use of its ROS1 inhibitor Jideytro (zidesamtinib) to patients starting treatment for the first time, after fresh results from the ARROS-1 study were presented at the World Conference on Lung Cancer in Seoul, South Korea. 15 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a partial clinical hold on Biohaven's investigational epilepsy drug opakalim (BHV-7000), pausing new patient enrollment in one of two pivotal Phase III trials pending further data on a metabolite identified in rodent testing, according to an 8-K filing. 14 September 2026
Pharmaceutical
Australian drugmaker Telix Pharmaceuticals’ shares rose 4.3% to A$16.34 today, after it announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer). 14 September 2026
Pharmaceutical
Last week’s regulatory news saw the US Food and Drug Administration (FDA) grant accelerated approval for AstraZeneca’s Etcamah combination for the treatment of breast cancer. On the research front, Novartis suffered another setback, this time with its Phase III trial miss for its myotonic dystrophy candidate delpacibart etedesiran (del-desiran). Roivant released positive Phase II results for its mosliciguat in the treatment of pulmonary hypertension, and AbbVie announced new Phase III data on its Qulipta (atogepant) supporting its leadership in the migraine space. 13 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Dutch biopharma firm Pharming’s supplemental New Drug Application (sNDA) for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years weighing at least 27 kg with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. 12 September 2026
Pharmaceutical
Three documents now define how the two largest medicines regulators think about artificial intelligence in drug development. The European Medicines Agency published a reflection paper in September 2024. The US Food and Drug Administration issued draft guidance in January 2025. In January 2026 the two agencies published a joint set of principles. 11 September 2026
Pharmaceutical
The Medicare Drug Price Negotiation Program is now running three cycles at once. Negotiated prices for the first ten products took effect in January 2026. A second set of 15 takes effect in January 2027. Talks on a third set of 15 close this autumn, and a fourth cycle is already in formal rulemaking. 11 September 2026
Biotechnology
Swiss pharma giant Roche today announced that the US Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). 10 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday granted accelerated approval for German pharma major Bayer’s Hyrnuo (sevabertinib), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. 10 September 2026
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