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Biotechnology News

Oxford Biomedica Signs Multi-Year Commercial Supply Deal With Bristol Myers Squibb

February 04, 2026 03:56 ET rttnewslogo20mar2024 lt

Oxford Biomedica plc (OXB.L), a cell and gene therapy contract development and manufacturing organization, on Tuesday said it has signed a new multi-year commercial supply agreement with Bristol-Myers Squibb Co. (BMY) to manufacture and supply lentiviral vectors for BMS' CAR-T programmes. Under the...

  • Novartis Q4 Profit Down, Sales Rise; Sees Higher Sales In FY26 February 04, 2026 01:13 ET

    Swiss drug major Novartis AG (NVS) reported Wednesday lower profit in its fourth quarter, despite sales growth. Further, the company lifted dividend, and issued fiscal 2026 outlook, expecting lower core operating income and higher net sales. In the fourth quarter, net income dropped 15 percent to...

  • Novartis AG Q4 Profit Falls February 04, 2026 01:09 ET

    Novartis AG (NVS) released earnings for fourth quarter that Drops, from last year The company's earnings came in at $2.404 billion, or $1.26 per share. This compares with $2.820 billion, or $1.42 per share, last year. Excluding items, Novartis AG reported adjusted earnings of $3.889 billion or...

  • Veradermics Prices IPO At $17 Per Share February 04, 2026 00:56 ET

    Veradermics, Incorporated (MANE), a late clinical-stage biopharmaceutical company, announced the pricing of its upsized initial public offering of 15.08 million shares at $17 per share. In addition, Veradermics has granted the underwriters a 30-day option to purchase up to an additional 2.26 million...

GSK Q4 Results Climb; Sees Growth In FY26, Backs 2031 Sales View - Update

February 04, 2026 02:42 ET Topstories2 30052024 lt

British drug major GSK plc (GSK, GSK.L) reported Wednesday higher profit and revenues in its fourth quarter, and issued fiscal 2026 outlook, expecting increase in core profit and turnover. Further, the firm reaffirmed its long-term outlooks, projecting 2031 sales outlook of more than 40 billion pounds. Looking...

GSK Plc Profit Rises In Q4

February 04, 2026 02:11 ET Topstories2 30052024 lt

GSK plc (GSK) revealed earnings for its fourth quarter that Increased, from last year The company's bottom line came in at GBP727 million, or GBP0.156 per share. This compares with GBP501 million, or GBP0.100 per share, last year. The company's revenue for the period rose 6.2% to GBP8.618 billion...

Pfizer's Monthly Injectable GLP-1 Delivers Strong, Sustained Weight Loss In Phase 2b Study

February 03, 2026 07:16 ET rttnewslogo20mar2024 lt

Pfizer Inc. (PFE) on Tuesday announced positive topline results from the Phase 2b VESPER-3 study evaluating monthly maintenance dosing of its ultra-long-acting, injectable GLP-1 receptor agonist PF'3944 in adults with obesity or overweight without type 2 diabetes. The study's dual objectives were...

Company Name
Drug
Event
Fortress Biotech Inc.
(FBIO)
CUTX-101 (Resubmitted NDA)
01/14/2026
FDA decision on CUTX-101 to treat Menkes disease in pediatric patients.
Johnson & Johnson
(JNJ)
TAR-200 (NDA)
01/17/2026
FDA decision on TAR-200 for the treatment of high-risk non-muscle invasive bladder cancer
AstraZeneca PLC
( AZN, AZN.L, ZEG.DE, AZN.ST)
ENHERTU (sBLA)
01/23/2026
FDA decision on ENHERTU in combination with Pertuzumab for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
Aquestive Therapeutics Inc.
(AQST)
Anaphylm (NDA)
01/31/2026
FDA decision on Anaphylm in the treatment of Type 1 allergic reactions, including anaphylaxis
Pharming Group N.V.
(PHGUF.PK, PHGUF.OB, PHAR, PHARM.AS)
Leniolisib (sNDA)
01/31/2026
FDA decision on expanded use of Leniolisib as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome
Regenxbio Inc
(RGNX)
Clemidsogene lanparvovec (RGX-121) (BLA)
02/08/2026
FDA decision on clemidsogene lanparvovec for the treatment of Mucopolysaccharidosis II (MPS II)
Merck & Co Inc.
(MRK)
KEYTRUDA (sBLA)
02/20/2026
FDA decision on KEYTRUDA plus chemotherapy with or without bevacizumab for treatment of patients with platinum-resistant recurrent ovarian cancer
VANDA PHARMACEUTICALS
(VNDA)
Bysanti (NDA )
02/21/2026
FDA decision on Bysanti (milsaperidone) for the acute treatment of bipolar I disorder and the treatment of schizophrenia
Eton Pharmaceuticals, Inc
(ETON)
ET-600 (NDA)
02/25/2026
FDA decision on ET-600 for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency
Otsuka Holdings Co., Ltd.
( OTSKF, 4578.T)
INQOVI (sNDA)
02/25/2026
FDA decision on INQOVI plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy

Biotech Stocks Facing FDA Decision In February 2026

January 27, 2026 22:44 ET drugs 19012026 lt

The FDA approved 46 novel drugs in 2025, with 70% receiving approval in the United States before any other country, according to a report from the Center for Drug Evaluation and Research (CDER). Several drugs are scheduled for FDA review this February. Will they pass the regulatory muster, or will they be sent back to the drawing board?

Biotechnology Weekly Update - March 19, 2025

March 19, 2025 09:33 ET
This week's video covers several intriguing topics: a merger of two pharma companies with a troubled past to create a global, diversified pharmaceuticals leader; a novel therapy in the works that could change the treatment landscape of Hunter syndrome, if approved; and a partnership to unlock Petrelintide’s potential for obesity treatment. Additionally, we explore the CDC's investigation into a potential link between vaccines and autism, amid the growing number of autism diagnoses.

HOOKIPA Pharma T0 Sell Oncology Assets HB-200 And HB-700 To NeoTrail Therapeutics

February 04, 2026 03:57 ET rttnewslogo20mar2024 lt

HOOKIPA Pharma Inc. (HOOK), a clinical-stage biopharmaceutical company, announced the sale of its immunooncology assets, Eseba-vec, also known as HB-200 and HB-700 development programs, to NeoTrail Therapeutics, Inc. HOOKIPA develops immunotherapeutics for cancer and other infectious diseases using...

Results Date
Company Name
Ticker
Event
Indication
Q1 2026
Nektar Therapeutics
Long-term data from Phase 2b Study of Rezpegaldesleukin (REZOLVE-AD)
Moderate-to-Severe Atopic Dermatitis
Q1 2026
Biocryst Pharmaceuticals Inc
Initial data from Phase I trial of BCX17725
Netherton syndrome
Q1 2026
Entera Bio Ltd.
Results from Phase 1 study of EB613
Post-Menopausal Women with Osteoporosis
Q1 2026
Provectus Pharmaceuticals Inc.
PVCT.OB
Results from preclinical study of PV-10
Orthotopic bladder cancer
Q1 2026
Oncolytics Biotech
ONCY, ONC.TO
Initial efficacy results from Cohort 5 of Phase 1/2 trial of pelareorep in combination with modified FOLFIRINOX with or without atezolizumab (GOBLET)
Newly diagnosed metastatic pancreatic cancer
Q1 2026
Astellas Pharma Inc.
ALPMY, 4503.T
Topline data from the 12-week Phase IIa study of ASC30 once-monthly subcutaneous depot treatment formulation
Obesity
Q1 2026
Ocular Therapeutix Inc.
52-week topline data from Phase 3 trial of AXPAXLI (SOL-1)
Wet age-related macular degeneration
Q1 2026
Theravance Biopharma Inc.
Topline results from Phase 3 study of ampreloxetine (CYPRESS)
Symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA)
Q1 2026
CytomX Therapeutics, Inc.
Data from Phase 1 trial of CX-2051 (varsetatug masetecan)
Colorectal Cancer
Q1 2026
vTv Therapeutics Inc.
Topline phase 3 data of cadisegliatin
Diabetes Mellitus, Type 1

South Carolina Measles Outbreak Breaks Record

February 03, 2026 05:53 ET measles 03022026 lt

A fast-growing measles outbreak in South Carolina, now the largest in recent U.S. history, has broken the record in the contagious disease reported in Texas last year. South Carolina's Department of Public Health announced that the number of confirmed cases has reached 789, eclipsing the record of...

  • Doctors Develop Artificial Lung System To Keep Missouri Man Alive Until Transplant February 02, 2026 14:16 ET

    A research team from Northwestern University in the US developed a total artificial lung (TAL) system that works like human lungs by adding oxygen to the blood. The system also helps control blood flow and reduces strain on the heart. The system was developed for a man from Missouri, who was airlifted...

  • Daily Use Of AI May Raise Emotional And Psychological Concerns, Study Finds February 02, 2026 13:27 ET

    New research found that using generative artificial intelligence (AI) every day may be linked to a higher risk of depressive symptoms and other negative effects, especially among younger and middle-aged adults. For this, researchers reviewed nearly 1.5 million conversations with Anthropic's Claude...

  • 1 Mln Air Travelers Participate In CDC Biosurveillance Program February 02, 2026 05:03 ET

    The Centers for Disease Control and Prevention has announced that its Traveler-Based Genomic Surveillance program has surpassed one million voluntary participants, marking a significant milestone in the United States' ability to detect and respond to emerging public health threats at its borders. TGS...

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