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Pharmaceutical
Among important regulatory news last week, the US Food and Drug Administration (FDA) approved Axsome Therapeutics’ Alzheimer’s agitation candidate Auvelity, and an FDA Advisory Committee voted against approval of AstraZeneca’s breast cancer drug camizestrant. US biotech Madrigal Pharma revealed a deal with Arrowhead Pharma to acquire rights to its investigational MASH treatment ARO-PNPLA3. Germany’s Bayer announced its proposed acquisition of Perfuse Therapeutic, aiming to reinforce it ophthalmics drug pipeline. 10 May 2026
Biotechnology
The US Food and Drug Administration (FDA) late Friday approved a label expansion for Netherlands-based argenx’ Vyvgart efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). 9 May 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved privately-held US biotech Partner Therapeutics’ (PTx) Bizengri (zenocutuzumab-zbco), a drug for adults with a rare form of bile duct cancer as part of a new fast-track review program, the agency said on Friday. 9 May 2026
Biotechnology
Privately-held French drugmaker Pierre Fabre Pharmaceuticals says it has reached agreement with the US Food and Drug Administration (FDA) on a potential path forward for resubmitting the Biologics License Application (BLA) for tabelecleucel, following a recent Type A meeting with the agency. 8 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators. 7 May 2026
Biotechnology
US biotech Arvinas and its partner Pfizer on Friday announced that the US Food and Drug Administration (FDA) has granted approval for Veppanu (vepdegestrant). Arvinas shares gained 6.2% to $10.51 on the news. 2 May 2026
Pharmaceutical
The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognized a favorable benefit risk profile for AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for treating patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. 1 May 2026
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced it is proposing to exclude semaglutide, tirzepatide and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. 1 May 2026
Pharmaceutical
AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the USA for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. 28 April 2026
Pharmaceutical
UK pharma major GSK today announced that efimosfermin, a once-monthly investigational liver therapy, has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). 27 April 2026
Biotechnology
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US Food and Drug Administration (FDA) for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. 27 April 2026
Pharmaceutical
Among significant news last week, Denmark’s Novo Nordisk presented positive results for its sickle cell disease candidate etavopivat. Eli Lilly revealed an up to $7 billion deal to acquire Kelonia Therapeutics and its gene therapy KLN-1010. The US Centers for Medicaid and Medicare Services (CMS) has extended the GLP-1 Bridge program for obesity medicines as insurers hold back. US biopharma Grace Therapeutics suffered a setback as the US Food and Drug Administration (FDA) issued a complete response letter (CRL) on the company’s new drug application (NDA) for GTx-104, which is being developed for aneurysmal subarachnoid hemorrhage (aSAH). 26 April 2026
Pharmaceutical
US President Donald Trump on April 18 issued an Executive Order directing the US Department of Health and Human Services to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions. 25 April 2026
Pharmaceutical
US biopharma Grace Therapeutics has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for GTx-104, sending the company’s shares down by 45% in Thursday's trading. 24 April 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for US biotech Regeneron Pharmaceuticals’ Otarmeni (lunsotogene parvec-cwha), the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program. 24 April 2026
Biotechnology
The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. 23 April 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved Sanofi’s supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. 22 April 2026
Biotechnology
The US Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) submitted by Japan’s Astellas Pharma and US pharma .giant Pfizer. 21 April 2026
Biotechnology
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). 21 April 2026
Pharmaceutical
The US Food and Drug Administration (FDA) is ramping up government efforts to curb misinformation on prescription drugs that endanger public health. This is in line with the presidential memorandum, which seeks to address misleading direct-to-consumer (DTC) prescription drug advertisements. 20 April 2026
Generics
Indian drugmaker Granules India has announced its US subsidiary has secured tentative approval from the American medicines regulator for amphetamine extended-release tablets, with eligibility for 180-day exclusivity. The product is a generic version of Dyanavel XR (amphetamine) for attention deficit hyperactivity disorder. 8 January 2026
Biosimilars
Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks begin on reauthorizing the scheme for another five years. BsUFA, which funds FDA’s biosimilar reviews through user fees, expires in September 2027 and will require new legislation to continue. 7 January 2026
Pharmaceutical
Switzerland-based Oculis Holding has announced that its neuroprotective candidate privosegtor was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for treatment of optic neuritis (ON). 6 January 2026
Biotechnology
In a slow news last week a mixed batch of clinical trials results featured. First, US biotech Ultragenyx announced disappointing Phase III results for its Osteogenesis Imperfecta (OI) candidate setrusumab, under development with Mereo BioPharm. Then InflaRx presented a new analysis of vilobelimab for pyoderma gangrenosum, and Pfizer disclosed a death in a long term Hympavzi study after thrombotic stroke. Also of note, after previous setbacks, the US Food and Drug Administration (FDA) granted approval for Vanda Pharmaceuticals’ motion sickness drug Nereus (tradipitant). 4 January 2026
Biotechnology
US biotech Ultragenyx Pharmaceutical In this week revealed that it has completed the rolling submission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA), seeking approval for DTX401 AAV gene therapy (pariglasgene brecaparvovec) as a treatment for glycogen storage disease Type Ia (GSDIa). 2 January 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for filing Axsome Therapeutics’ supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer’s disease agitation. 2 January 2026
Biotechnology
US gene therapy company Regenxbio’s clemidsogene lanparvovec has a plausible pathway to US Food and Drug Administration (FDA) approval in Hunter syndrome, although the decision will likely hinge on whether biomarker reductions can be convincingly linked to meaningful clinical outcomes, experts tell the insights investigative news team at GlobalData. 31 December 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion from Vanda Pharmaceuticals, whose shares rose as much as 18% to $8.29 on the news. 31 December 2025
Pharmaceutical
The US Food and Drug Administration (FDA) spent much of 2025 in the spotlight. Through steady drug approvals, renewed emphasis on transparency, and concrete steps to modernize its operations, the FDA’s actions this year helped shape expectations for 2026. 30 December 2025
Biotechnology
Despite the US Food and Drug Administration’s (FDA) acceptance of Inovio’s Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with recurrent respiratory papillomatosis (RRP), Monday was still a bleak day for the Pennsylvania firm. 29 December 2025
Pharmaceutical
M&A news last week featured French pharma major Sanofi announcing an agreement to acquire US vaccine maker Dynavax Technologies for around $2.2 billion, as well as a setback with its multiple sclerosis drug tolebrutinib. On the regulatory front, USA-based Omeros revealed that its Yartemlea had received Food and Administration (FDA) approval for TA-TMA. Also, US drugmaker Agios Pharmaceuticals won FDA approval for its Aqvesme as a first oral anemia treatment across thalassaemia. 28 December 2025
Biotechnology
Seattle, USA-based biotech Omeros Corp saw its shares leap 75.5% to $15.36 by close of trading Wednesday, as it revealed that the US Food and Drug Administration (FDA) has approved its Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). 26 December 2025
Pharmaceutical
US rare disease specialist Agios Pharmaceuticals has won approval for Aqvesme (mitapivat) to treat anemia in adults with alpha- or beta-thalassaemia, covering both non-transfusion-dependent and transfusion-dependent forms. The oral therapy is the first authorised for this broad patient population. 24 December 2025
Pharmaceutical
French pharma major Sanofi has received a Complete Response Letter (CRL) from the US regulator for tolebrutinib in non-relapsing secondary progressive multiple sclerosis, extending a difficult run for the experimental therapy. The decision blocks approval of the oral Bruton’s tyrosine kinase inhibitor in adult patients. 24 December 2025
Biosimilars
German biosimilars specialist Formycon has won US approval for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, strengthening its ophthalmology footprint in the USA. The US regulator cleared the product under a Biologics License Application. 24 December 2025
Pharmaceutical
Danish drugmaker Novo Nordisk has secured US approval for an oral version of Wegovy (semaglutide), expanding access to its blockbuster weight-loss franchise. 23 December 2025
Biotechnology
Once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) therapy has moved into a new phase with Food and Drug Administration (FDA) approval of US privately-held biotech LIB Therapeutics’ Lerochol (lerodalcibep-liga) for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). 23 December 2025
Biotechnology
Since the drug’s approval, the US Food and Drug Administration (FDA) says it has received post-marketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with AstraZeneca’s Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo. 22 December 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab), from Roche, as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. 22 December 2025
Biotechnology
UK pharma major AstraZeneca and Japan’s Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy designation (BTD) in the USA for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence. 22 December 2025
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