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Pharmaceutical
The US Food and Drug Administration (FDA) has determined that only a clinical trial - rather than a nonclinical or observational study - will be sufficient to prove the safety of Eli Lilly’s new obesity drug, Foundayo (orforglipron). 15 April 2026
Biotechnology
The US Food and Drug Administration (FDA) today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies. 14 April 2026
Pharmaceutical
US biopharma Travere Therapeutics has announced that the US Food and Drug Administration (FDA) has approved Filspari (sparsentan) to reduce proteinuria in adult and pediatric patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. 14 April 2026
Biotechnology
Anglo-Irish biopharma SynOx Therapeutics announced that the US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to emactuzumab for the treatment of tenosynovial giant cell tumors (TGCT) patients that are not amenable to or who would not benefit from surgery. 14 April 2026
Biotechnology
Important news last week kicked off with Neurocrine Biosciences announcing a proposed $2.9 billion takeover bid for Solena Therapeutics. Then Gilead Sciences revealed an up to $5 billion takeover for German antibody-drug conjugate (ADCs) developer Tubulis. Also of note, Sanofi released mixed Phase II results for its asthma and dermatology candidate lunsekimig. The US Food and Drug Administration (FDA) announced plans for greater control of direct-to-consumer Rx medicines advertising. 12 April 2026
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
Biotechnology
Japan’s Eisai and US biotech Biogen have announced that the US Food and Drug Administration (FDA) has accepted for review the former’s Supplemental Biologics License Application (sBLA) for lecanemab-irmb subcutaneous autoinjector (SC-AI), branded as Leqembi Iqlik, as a weekly starting dose. 26 January 2026
Pharmaceutical
Sweden-headquartered contract development and manufacturing organization (CDMO) Recipharm has developed a new, dedicated manufacturing facility to meet the latest regulatory expectations for non-bacterial beta-lactam medicines. This investment responds to regulatory guidance and to growing customer demand for compliant, dedicated manufacturing solutions. 26 January 2026
Biosimilars
South Korea’s Samsung Bioepis today released its first quarter 2026 biosimilar market report, marking the twelfth edition of the Quarterly Biosimilar Market Report in the United States (US) today. 23 January 2026
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations. 21 January 2026
Biotechnology
Calfornian immunotherapy company ImmunityBio has announced that it has held a Type B End-of-Phase meeting with the US Food and Drug Administration (FDA) regarding the company’s supplemental Biologics License Application (sBLA) for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. 20 January 2026
Biotechnology
French vaccine maker Valneva has abandoned its near-term US plans for its chikungunya vaccine Ixchiq, voluntarily withdrawing both its biologics license application and its investigational new drug filing after the American medicines regulator tightened the screws on safety. 20 January 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease, the Swiss pharma giant announced late Friday. 17 January 2026
Pharmaceutical
As many as four decisions under the US Food and Drug Administration’s (FDA) new fast-track program have been delayed, Reuters has reported. 16 January 2026
Biotechnology
Indian drug major Sun Pharmaceutical Industries yesterday announced that Unloxcyt (cosibelimab-ipdl) is now available in the USA for healthcare professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 16 January 2026
Pharmaceutical
After several months of collaboration, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a common set of 10 guiding principles to inform, enhance, and promote the use of artificial intelligence (AI) for generating evidence across all phases of the drug product life cycle. 15 January 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for French drugmaker Ipsen’s IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. 14 January 2026
Pharmaceutical
The US Food and Drug Administration yesterday approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. The FDA approved Zycubo, previously known as CUTX-101, for Sentynl Therapeutic, a part India’s Zydus Lifesciences which filed the regulatory filing and is partnered with Fortress Biotech.
. 14 January 2026
Biotechnology
Taiwan-based PharmaEssentia Corporation, a biopharma seeking to deliver new biologics in hematology and oncology, has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for ropeginterferon alfa-2b-njft for the treatment of adult patients with essential thrombocythemia (ET). 13 January 2026
Pharmaceutical
Germany’s Merck KGaA has announced that the US Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). 13 January 2026
Biotechnology
The US Food and Drug Administration (FDA) has released information on what it calls its flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). 12 January 2026
Pharmaceutical
US drugmaker Vanda Pharmaceuticals yesterday announced that it has received a decision letter from the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form. 9 January 2026
Pharmaceutical
New Jersey, USA-based Aquestive Therapeutics saw its shares plummet nearly 48% to $3.25 (Nasdaq: AQST) pre-market today, after it provided an update on the regulatory approval of Anaphylm, noting receipt of a Food and Drug Administration (FDA) letter saying the agency has found deficiencies in the new drug application (NDA) that preclude discussion of labeling and post-marketing commitments at this time related to Anaphylm (sublingual film epinephrine formulation) in type I allergic reactions. 9 January 2026
Pharmaceutical
An Expert View from Steve Bulera, CVP and CSO, Discovery and Safety Assessment, Charles River. 8 January 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
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