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New dosing approved for Lilly’s Kisunla in Alzheimer’s

The US Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Eli Lilly's once-monthly amyloid-targeting therapy for early symptomatic Alzheimer's disease (AD), including patients with mild cognitive impairment (MCI) and the mild dementia stage of AD, with confirmed amyloid pathology. 9 July 2025

Agencies up efforts to cut animal testing

The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have hosted a hybrid workshop on reducing animal testing. 9 July 2025

KalVista wins FDA greenlight for Ekterly

USA and UK-based KalVista Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Ekterly (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. 7 July 2025

The week in pharma: action, reaction and insight – week to July 4

US pharma major AbbVie announced it plan to acquire Capstan Therapeutics, along with its autoimmune disease candidate CPTX2309, for up to $2.1 billion. Organon posted disappointing mid-stage trial results for its investigational endometriosis pain drug, OG-6219. Also of note last week, the US Food and drug Administration (FDA) granted accelerated approval for Regeneron’s multiple myeloma drug Lynozyfic. 6 July 2025

FDA accelerated approval for Dizal’s sunvozertinib

The US Food and Drug Administration has granted accelerated approval to sunvozertinib (trade name Zegfrovy) from Dizal (Jiangsu) Pharmaceutical for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 3 July 2025

FDA steps up assessment of myocarditis following mRNA COVID-19 jabs

The US Food and Drug Administration (FDA) has provided an update on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men. 3 July 2025

Regeneron wins FDA accelerated approval for Lynozyfic in MM

The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody. 3 July 2025

FDA grants priority review to Merck's Winrevair

US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) to update the US product label for Winrevair (sotatercept-csrk) based on the Phase III ZENITH trial. 2 July 2025

Unicycive hit with CRL on oxylanthanum carbonate NDA

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Unicycive Therapeutics’ New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, but still sending the California-based company's share shares nearly 5% higher to $5.00. in pre-market activity. 1 July 2025

Enhanced labeling on weight loss risk in children taking extended-release stimulants for ADHD

The US Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD)—including certain formulations of amphetamine and methylphenidate—to warn of the risk of weight loss and other adverse reactions in patients younger than six years. 1 July 2025

FDA approves Takeda’s Gammagard liquid ERC

1 July 2025

FDA drops REMS for CAR-T therapies

The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies. 30 June 2025

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FDA approves Gamifant for HLH/MAS in Still’s disease

Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi on Frida,y announced that the US Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for a new indication, edging the company’s shares up 2.4% to 284.60 kronor. 28 June 2025

Merck’s RSV antibody Enflonsia gets ACIP backing for infant use

US pharma major Merck & Co has secured a key endorsement for its newly approved respiratory syncytial virus (RSV) prevention product, Enflonsia (clesrovimab), as a majority of an influential advisory panel voted to recommend its use in newborns ahead of the 2025-2026 RSV season. 27 June 2025

FDA approves required updated warning in COVID-19 vaccine labeling

The US Food and Drug Administration (FDA) has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer and Spikevax (COVID-19 Vaccine, mRNA) manufactured Moderna to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. 26 June 2025

FDA grants RMAT designation for enGene’s detalimogene

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (previously known as EG-70), Canadian company enGene’s lead investigational therapy for the treatment of high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). 26 June 2025

Senator seeks delay of vaccine committee meeting amid sceptic worries

Republican Senator Bill Cassidy has called for Wednesday’s meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) to be delayed. 25 June 2025

Data keeps Nuvalent on track for rolling zidesamtinib NDA

Nuvalent, a US biopharma developing precisely targeted therapies for clinically-proven kinase targets in cancer, has announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). 24 June 2025

Datroway first US-approved TROP2-directed therapy in lung cancer

The US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan or Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. 24 June 2025

Industry anger at FDA oustings

The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 countries, including emerging and established biotech firms, has taken aim at the powers that be in US healthcare. 23 June 2025

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FDA grants expanded approval for Anktiva

The US Food and Drug Administration (FDA) approved Anktiva (nogapendekin alfa inbakicept-pmln) from Altor BioSciences, an indirect wholly-owned subsidiary of ImmunityBio, with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). 15 October 2026

Formycon and Zydus’s Keytruda biosimilar BLA accepted by FDA

Germany’s Formycon and India’s Zydus Lifesciences jointly announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda (pembrolizumab). 13 October 2026

Asahi Kasei wins FDA approval for Hovilpri

The Food and Drug Administration (FDA) has approved Hovilpri (pritelivir) 100mg tablets for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacyclovir, or famciclovir in immunocompromized adults. 12 October 2026

Foreign clinical trial data: FDA draws a firmer line

The US Food and Drug Administration (FDA) has signaled a clear shift in how it intends to scrutinize clinical trial data generated outside the USA. In a September 2026 statement co-authored by the leaders of its drug, biologics, device, and oncology centers, the agency stated that good clinical practice (GCP) “is not a bureaucratic formality” and that geography does not change the evidentiary standard.1 12 October 2026

Pharmacological advances in rare diseases

September 2026 brought a series of important advances in rare disease treatment, with several therapies receiving their first regulatory approvals. 12 October 2026

FDA approves Teva’s Weltruza for schizophrenia

Israel-based Teva Pharmaceutical Industries US subsidiary today revealed that the US Food and Drug Administration (FDA) has approved Weltruza (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. 9 October 2026

New FDA approval for Roche’s Tecentriq

The US Food and Drug Administration (FDA) has approved oche’s Tecentriq atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. 9 October 2026

Newron details FDA safety concerns behind evenamide hold, says Phase III continues

Italian neuroscience company Newron Pharmaceuticals has set out the US Food and Drug Administration's (FDA) reasons for the clinical hold at US sites in its Phase III ENIGMA-TRS 2 trial of evenamide in treatment-resistant schizophrenia (TRS), and said it is preparing a response. 8 October 2026

Ultragenyx to sell rare PRV for $210 million

US rare diseases specialist Ultragenyx Pharmaceutical announced it has entered into a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $210 million. 8 October 2026

Novartis' Rhapsido gains new FDA approval

The US Food and Drug Administration (FDA) approved Swiss pharma giant Novartis’ Rhapsido (remibrutinib), an oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi), as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines. 8 October 2026

Pfizer’s Tukysa regimen wins another FDA approval

US pharma giant Pfizer yesterday revealed that the US Food and Drug Administration (FDA) has approved Tukysa (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer following induction treatment. 8 October 2026

AbbVie’s Temab-A receives two FDA Breakthrough statuses

The US Food and Drug Administration (FDA) has granted two Breakthrough Therapy designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC), from US pharma major AbbVie. 8 October 2026

Vaxcyte leaps on positive Phase III trial of VAX-31

Shares of Vaxcyte, a US clinical-stage vaccine innovation company, rocketed as much as 90% in pre-market activity today announced positive top-line results from the OPUS-1 pivotal adult Phase III trial evaluating the safety, tolerability and immunogenicity of VAX-31. 5 October 2026

FDA approves expanded use of BMS’ Camzyos

The US Food and Drug Administration (FDA) approved Camzyos (mavacamten), from Bristol Myers Squibb for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms in adults and pediatric patients weighing 30 kg (66 lbs) or more. 2 October 2026

Roche’s fenebrutinib filing accepted by FDA

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), Swiss pharma giant Roche said. 30 September 2026

Orexo resubmits NDA for Izipry to the FDA

Sweden’s Orexo today announced the resubmission of the New Drug Application (NDA) for Izipry (naloxone nasal powder) to the US Food and Drug Administration (FDA) was completed on September 29, 2026. 29 September 2026

FDA nod for Teva’s Degevma biosimilar

Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has approved Degevma (denosumab-adet) as a biosimilar to Xgeva (denosumab). 29 September 2026

FDA grants approval for Egetis’ Emcitate

Sweden’s Egetis Therapeutics stock surged 13.2% to reach 8.42 kronor, hitting a new 52-week high of 8.85 kronor intraday, after the US Food and Drug Administration (FDA) formally approved Emcitate (tiratricol) - a thyroid hormone receptor agonist. 29 September 2026

FDA approves AbbVie's Juvmo, first D1/D5 receptor agonist for Parkinson's

Chicago-based drugmaker AbbVie said the US Food and Drug Administration (FDA) has approved Juvmo (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for adults with Parkinson's disease, taken once daily with or without levodopa. 28 September 2026

Merck and Daiichi withdraw US filing for lung cancer ADC

US pharma major Merck & Co and Japanese drugmaker Daiichi Sankyo have voluntarily withdrawn their application for accelerated US approval of ifinatamab deruxtecan (I-DXd), following feedback from the US regulator, the Food and Drug Administration (FDA). 28 September 2026

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