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Pharmaceutical
USA-based neurodegenerative disorders specialist Annovis Bio today revealed that it has secured financing to support the development of its investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s and Parkinson’s. 10 April 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has outlined a number of legislative proposals in its fiscal 2027 budget request. 8 April 2026
Generics
The US Food and Drug Administration approved the first generics of UK pharma major AstraZeneca’s Farxiga (dapagliflozin) tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 8 April 2026
Pharmaceutical
In 2025, US contract manufacturing deals for US Food and Drug Administration (FDA)-approved drugs posted their steepest decline in five years. Despite record-high US tariffs on EU pharmaceuticals, biopharma companies, including US-based firms, are increasingly choosing to outsource manufacturing for the US market to facilities in Europe rather than shifting work to domestic providers. 7 April 2026
Pharmaceutical
The past week produced a thinner regulatory crop than some recent weeks, but there were still several reportable human-medicines developments across major agencies. The clearest headline came from the US Food and Drug Administration, which approved Foundayo (orforglipron) under its National Priority Voucher program. 7 April 2026
Pharmaceutical
Important research news last week included US pharma giant Merck & Co moving its Winrevair into Phase III for pulmonary arterial hypertension. On the M&A front, Biogen announced a $5.6 billion takeover for Apellis and its two main products – Empaveli and Syfovre. Eli Lilly’s oral obesity drug orforglipron has been granted US Food and Drug Administration (FDA) in a record time, under the trade name Foundayo. Also of note, Sino-American biotech Adagene struck a deal with the USA’s Incyte to evaluate muzastotug in colorectal cancer. 5 April 2026
Biotechnology
Privately-held US cell therapy company Orca Bio announced that the US Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. 2 April 2026
Pharmaceutical
Precision oncology start-up Fore Biotherapeutics announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG). 2 April 2026
Pharmaceutical
US drugmaker Vertex Pharmaceuticals today announced the US Food and Drug Administration (FDA) has approved expanded indications for two of its top-selling drugs. 1 April 2026
Biotechnology
The US Food and Drug Administration (FDA) is alerting patients and health care professionals about serious post-marketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with US biotech major Amgen’s Tavneos (avacopan). 1 April 2026
Biosimilars
Israel-based Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. 30 March 2026
Biotechnology
March 2026 marked a significant inflection point for rare disease therapeutics, as regulatory momentum, policy pressure, and scientific innovation converged. 30 March 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval to Kresladi (marnetegragene autotemcel) for the treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I), US biotech Rocket Pharmaceuticals announced today. 27 March 2026
Biotechnology
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
Generics
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
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
Pharmaceutical
Barcelona, Spain-based Grifols announced that its fibrinogen concentrate, Fesilty (fibrinogen, human-chmt), has been approved by the US Food and Drug Administration (FDA) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. 22 December 2025
Pharmaceutical
Regulatory news of note last week included the US Food and Drug administration (FDA) approving two new treatments for gonorrhea – Innoviva’s Nuzolvence and GSK’s Blujepa. Research news saw positive results for Kyverna mid-stage candidate mivocabtagene-autoleucel (Miv-cel)l and new data from Eli Lilly on its obesity candidate orforglipron. Neurocrine Bioscience held an R&D Day focused on its neuroscience and endocrinology pipeline, notably direclidine and osavampator. 21 December 2025
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim on Friday revealed that its Jascayd (nerandomilast) tablets has now been approved by the US Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. 20 December 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. 20 December 2025
Pharmaceutical
Danish pharma major Novo Nordisk has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for once-weekly CagriSema (cagrilintide and semaglutide) injection, to be used with a reduced-calorie diet and increased physical activity. 19 December 2025
Biotechnology
US healthcare giant Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Rybrevant Fasbro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). 18 December 2025
Biotechnology
UK pharma major GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. 18 December 2025
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