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The week in pharma: action, reaction and insight – week to May 8, 2026

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

FDA expands approval of argenx’ VyvgartFDA expands approval of argenx’ Vyvgart

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

FDA nod for Partner Therapeutics’ Bizengri

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

Pierre Fabre outlines FDA path forward for tabelecleucel after setback

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

FDA expands AI capabilities

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

FDA nod for Arvinas and Pfizer’s Veppanu

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

Favorable benefit risk recognition from FDA Committee for AstraZeneca’s Truqap

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

FDA to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list

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

AstraZeneca’s Breztri approved in USA for asthma

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

GSK’s efimosfermin wins FDA/EMA priority designations

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

AstraZeneca’s Saphnelo approved in the USA

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

The week in pharma: action, reaction and insight – week to April 24, 2026

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

FDA accelerates action on mental illness therapies following Executive Order

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

Grace hit by CRL for GTx-104, shares plunge 45%

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

Regeneron wins FDA approval for Otarmeni, first gene therapy for genetic hearing loss

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

New FDA indication for Sanofi and Regeneron’s Dupixent

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

Sanofi's Tzield approved in USA for children

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

FDA grants priority review to sBLA for Padcev + Keytruda

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

FDA accepts sBLA for Roche’s Gazyva/Gazyvaro for lupus

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

FDA tightens oversight of drug promotion

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

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Novo Nordisk’s Awiqli approved by FDA

Danish pharma major Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes. 27 March 2026

FDA publishes 2025 GDUFA science and research report

The US Food and Drug Administration FDA’s Center for Drug Evaluation and Research published its fiscal year 2025 Generic Drug User Fee Amendments (GDUFA) Science and Research Report at https://www.fda.gov/drugs/generic-drugs/fy-2025-gdufa-science-and-research-report. 27 March 2026

FDA orders warning for Parkinson’s mainstay after seizure cases

The US Food and Drug Administration is requiring new label warnings for widely used Parkinson’s therapies combining levodopa and carbidopa, citing a risk of vitamin B6 deficiency that may trigger seizures. 26 March 2026

FDA wastes no time in approving Corcept’s Lifyorli

More than two months before the US Food and Drug Administration (FDA) deadline date for a decision, the agency has approved Corcept Therapeutics’ Lifyorli (relacorilant) in ovarian cancer, sending shares in the firm 18% higher Wednesday. 26 March 2026

FDA approves drug to treat neurologic manifestations of Hunter syndrome

The US Food and Drug Administration (FDA) yesterday approved Denali Therapeutics’ Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II). 26 March 2026

FDA approves Adstiladrin label update

The US Food and Drug Administration (FDA) has approved a label update for Ferring’s Adstiladrin (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. 25 March 2026

Rhythm wins US nod for Imcivree in rare hypothalamic obesity

US biotech Rhythm Pharmaceuticals has secured US regulator approval for Imcivree (setmelanotide) in acquired hypothalamic obesity, marking the first approved treatment for the rare condition characterized by rapid weight gain and severe hunger. 23 March 2026

FDA approval for Opdivo in previously untreated Hodgkin lymphoma

On March 20, 2026, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s Opdivo (nivolumab) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). 23 March 2026

The week in pharma: action, reaction and insight – week to March 20, 2026

Significant research news last week included US biotech CytomX Therapeutics releasing positive new data on its colorectal cancer candidate varsetatug masetecan (VarsetaM). Pfizer reported encouraging data on its investigational breast cancer drug atirmociclib, which could be a successor for its Ibrance, and Eli Lilly posted new Phase III data on its diabetes candidate retatrutide. Also of note, Johnson & Johnson and Protagonist’s gained US Food and Drug Administration (FDA) approval for their plaque psoriasis drug Icotyde (icotrokinra). 22 March 2026

US launch of two Glenmark generics announced

Indian drugmaker Glenmark Pharmaceuticals has announced the introduction of two generic products to the US market. 20 March 2026

GSK’S Lynavoy approved by the US FDA

UK pharma major GSK has announced that the US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. 20 March 2026

Following FDA nod, Novo Nordisk expects to launch Wegovy HD in the USA in April

Danish pharma major Novo Nordisk (NOV: N) late Thursday announced that the US Food and Drug Administration (FDA) has approved Wegovy HD (once-weekly injectable semaglutide 7.2mg) to reduce excess body weight and maintain weight reduction long-term. 20 March 2026

Sarepta cleared to re-submit sNDAs for Amondys and Vyondys

US rare disease drug developer Sarepta Therapeutics today provided an update on its ongoing regulatory interactions with the US Food and Drug Administration (FDA) regarding Amondys 45 (casimersen) and Vyondys 53 (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD). 19 March 2026

FDA greenlight for J&J’s Icotyde

The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients. . 18 March 2026

Regulatory milestone for Sanofi’s venglustat in type 3 Gaucher disease

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Sanofi’s venglustat, a novel, investigational oral glucosylceramide synthase inhibitor, to treat neurological manifestations of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder. 18 March 2026

Novartis’ Cosentyx wins new FDA approval

Swiss pharma giant Novartis late Friday announced today that Cosentyx (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only interleukin (IL)-17A inhibitor for this population. 16 March 2026

FDA launches new adverse event look-up tool

The US Food and Drug Administration (FDA) yesterday launched a new unified platform for analyzing adverse event reports. This platform - called the FDA Adverse Event Monitoring System (AEMS) - represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products. 12 March 2026

FDA nod for Wellcovorin in rare genetic disorder

The US Food and Drug Administration (FDA) has approved expanded use of Wellcovorin (leucovorin calcium) tablets to treat cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (-FOLR1). 10 March 2026

FDA hopes for major impact of Niazi proposals on biosimilar development

The US Food and Drug Administration (FDA) has released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4). 10 March 2026

Enhertu closer to US approval in new indication

A supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the USA for the treatment of HER2-positive breast cancer patients with residual invasive disease after neoadjuvant HER2-targeted treatment. 9 March 2026

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