BRISBANE, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with...Read more
CLEARWATER, Fla., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apyx® Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, is pleased to announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System. The AYON Body Contouring System was...Read more
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium...Read more
Six-month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for June 30, 2025 CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric disease SOLANA BEACH, Calif. and AHMEDABAD, India and MIAMI, Jan. 6, 2025 /PRNewswire/ -- Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences,...Read more
If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy BLA submission triggers $10 million milestone payment to Capricor from Nippon Shinyaku SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of the...Read more
PRINCETON, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride Tablets. ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity®. "We are delighted to build momentum...Read more
REDWOOD CITY, Calif. / Dec 30, 2024 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol...Read more
Secures Access of Up To $30 Million to Support Potential Launch Through Silicon Valley Bank Credit Facility DURHAM, N.C., Dec. 30, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today confirms that the Company has submitted a New Drug Application (NDA) with the U.S. Food and Drug...Read more
PDUFA target action date is June 30, 2025 If approved, avutometinib in combination with defactinib would be the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC BOSTON / Dec 30, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has...Read more
GOLETA, Calif. / Dec 30, 2024 / Business Wire / Inogen, Inc. (Nasdaq: INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SIMEOX 200 Airway Clearance Device, expanding the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the...Read more
Aiming to be the first FDA-approved medication to treat suicidal depression Designed to help address the needs of the more than 13 million Americans who seriously consider suicide each year (CDC) Completion of NDA filing expected in the first quarter of 2025 Company to participate in 1x1 meetings in San Francisco during the Annual J.P. Morgan Healthcare Conference on January 13-16, 2025, in San Francisco, CA. To schedule...Read more
PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of adults with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries PRGN-2012 received Breakthrough Therapy Designation from the FDA and Orphan Drug Designation from the FDA and the European Commission The BLA, under an accelerated approval pathway, is supported by data from the Phase 1/2 pivotal...Read more
MELBOURNE, Australia and INDIANAPOLIS, Dec. 30, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2. TLX250-CDx is an investigational PET3 drug product for the non-invasive diagnosis...Read more
Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor1 Given over three- to five-minutes, Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to intravenous Opdivo in the Phase 3 CheckMate-67T trial1,3 PRINCETON, N.J. / Dec 27, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo...Read more
New indication based on results from a global Phase 3 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival for patients with advanced gastric cancers Second FDA approval for TEVIMBRA in 2024 SAN MATEO, Calif. / Dec 27, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the...Read more
VALENCIA, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini. As a line extension of the RECELL GO system, the RECELL GO mini disposable...Read more
New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC U.S. Food and Drug Administration (FDA)...Read more
ALISO VIEJO, Calif. / Dec 23, 2024 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy for the...Read more
BRAFTOVI in combination with cetuximab and mFOLFOX6 is the first and only combination regimen with targeted therapy approved for use as early as first-line for patients with metastatic colorectal cancer with a BRAF V600E mutation Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the Phase 3 BREAKWATER trial NEW YORK / Dec 20, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that...Read more
Averaging up to 20% of weight loss, adults taking Zepbound had at least 25 fewer breathing interruptions each hour as they slept Up to 50% of adults taking Zepbound no longer had symptoms associated with OSA after one year INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription...Read more
ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV1 and further decreased sweat chloride compared to TRIKAFTA® BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug...Read more
Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time BOSTON / Dec 20, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with...Read more
BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to include children as young as 2 years old. IMCIVREE is indicated to reduce excess...Read more
WASHINGTON, Dec. 20, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2000 Americans.1 PV is a chronic myeloproliferative...Read more
Unique cell-impermeable1 design extends life-saving treatment for dialysis patients Merit to host a WRAPSODY informational call on January 28, 2025 SOUTH JORDAN, Utah, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that the WRAPSODY® Cell-Impermeable Endoprosthesis has received premarket approval from the US Food and...Read more
THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This expected communication...Read more
SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection Highly experienced sales team already recruited and trained in preparation for commercial launch DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE) --...Read more
TRYNGOLZA shown to significantly reduce triglycerides and substantially reduce acute pancreatitis events in adults with FCS; a rare, highly debilitating and life-threatening disease Indicated for adults with FCS regardless of genetically or clinically confirmed diagnosis TRYNGOLZA is the first of four independent launches planned over the next three years, pending approvals Ionis to host webcast today at 6:45pm ET...Read more
New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDerm Cohealyx expected to triple AVITA Medical’s addressable market in burns VALENCIA, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S....Read more
MIAMI, FLORIDA / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND...Read more
If approved, vatiquinone would be the first and only authorized therapy for children with FA PTC's fourth approval application submitted to FDA in 2024 WARREN, N.J., Dec. 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the vatiquinone New Drug Application (NDA) for the treatment of children and adults living with Friedreich ataxia (FA) to the U.S. Food and Drug...Read more
WARREN, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) to Libervant® (diazepam) Buccal Film for the acute...Read more
NOVATO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or the Agency) seeking accelerated approval for UX111 (ABO-102) AAV gene therapy as a treatment for patients with Sanfilippo syndrome type A (MPS IIIA). “The path to get a treatment to the point of a BLA filing has been long...Read more
SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK), for the treatment of...Read more
RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication. RYONCIL is the first FDA-approved therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates. In a single-arm, multi-center, Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or...Read more
Company Expects to Complete BLA Submission by End of 1Q 2025 LANGHORNE, Pa. / Dec 18, 2024 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, initiated a rolling submission of a BLA to the FDA for MOLBREEVI for the potential treatment of aPAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant...Read more
MONTREAL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility...Read more
Dravet syndrome is a genetic developmental and epileptic encephalopathy (DEE) often caused by a mutation in SCN1A This is the third Rare Pediatric Disease Designation for relutrigine, adding to those granted for SCN2A and SCN8A DEEs Praxis plans to initiate an all-DEE trial (EMERALD), inclusive of Dravet syndrome, in 1H2025 BOSTON, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage...Read more
FOSTER CITY, Calif. / Dec 17, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. The Breakthrough Therapy Designation is...Read more
World Health Organization (WHO) has classified the global resurgence of cholera at the highest internal level for emergencies; 1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-related deaths occur each year worldwide Cholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae Crofelemer previously granted orphan-drug designation by the FDA and the European Medicines Agency...Read more
SALT LAKE CITY, Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical...Read more
FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for...Read more
If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the U.S. in time for the 2025-26 season RAHWAY, N.J. / Dec 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational...Read more
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food & Drug Administration for a stemless anatomic total shoulder for the AETOS Shoulder System (AETOS Stemless). AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint allowing for an efficient procedure.1 It is...Read more
CHICAGO / Dec 16, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a “rare pediatric disease.” “THIO is a versatile anti-cancer agent that has demonstrated positive...Read more
First cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in...Read more
ZORYVE cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trials Roflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile for up to 56 weeks of treatment Approximately 1.8 million children with atopic dermatitis (AD) aged 2 to 5 are topically treated in the United States WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics,...Read more
EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up to 46% of patients on VTAMA cream achieved vIGA-AD™ treatment success at Week 8 versus 18% of patients on vehicle. POWERFUL SKIN CLEARANCE: The majority of patients entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week open-label ADORING long-term extension (LTE) study and remained treatment-free (remittive effect) for an average of ~80...Read more
CRENESSITY, the first new treatment available in 70 years to the classic congenital adrenal hyperplasia (CAH) community, offers a paradigm-shifting treatment approach FDA approval supported by data from the largest-ever clinical trial program in pediatric and adult patients with classic CAH CRENESSITY is expected to be commercially available in approximately one week Rare Pediatric Disease Priority Review Voucher granted in...Read more
WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only...Read more
New Anatomically Shaped Asymmetric Stemless Design for Total Shoulder Replacement WARSAW, Ind., Dec. 13, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the OsseoFit™ Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to match the natural...Read more
Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025 SAN FRANCISCO / Dec 12, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough...Read more
COPENHAGEN, Denmark, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA® for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27,...Read more
IMM-1-104 has the potential to benefit melanoma patients who have progressed on or are intolerant to immune checkpoint inhibitors IMM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative to MEK inhibitors currently used to treat melanoma Melanoma patients actively enrolling in one of five arms in the company’s ongoing Phase 2a clinical study of IMM-1-104 CAMBRIDGE, Mass.,...Read more
TORONTO and PHILADELPHIA, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (TSXV: MDCX) ("Medicus" or the "Company") is pleased to announce that its Investigational New Animal Drug (INAD File No.013880) has received Minor Use in Major Species Designation (“MUMS”) from the U.S. Food and Drug Administration (“FDA”) for its dissolvable Doxorubin-containing microneedle array (D-MNA) to treat external squamous cell...Read more
The Type C meeting with the FDA, combined with the recent 18-month Phase 2b PARADIGM study readout, has the Company on track to commence a Phase 3 study in mid-2025 PrimeC has already demonstrated a significant impact on slowing disease progression and increasing survival rates in people living with ALS CAMBRIDGE, Mass., Dec. 11, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage...Read more
Phase 1a Trial of STAR-0310 in Healthy Volunteers Expected to Initiate in Q1 2025 Early Proof-of-Concept Results Expected in Q3 2025 BOSTON / Dec 10, 2024 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New...Read more
BELTSVILLE, Md., Dec. 10, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting...Read more
New Dosing Regimen Simplifies Administration NASHVILLE, Tenn., Dec. 9, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced today the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote® (N-acetylcysteine for injection) product. Acetadote is an intravenous (IV) formulation of...Read more
Potential Approval in Q3 2025 in Recurrent H3 K27M-Mutant Diffuse Glioma Submission Plan Follows Productive and Collaborative Pre-NDA Interactions with FDA Company to Host Conference Call on Tuesday, December 10 at 8:30 AM ET DURHAM, N.C., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients...Read more
ATLANTA, Dec. 9, 2024 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) for use of the AMDS Hybrid Prosthesis ("AMDS") in acute DeBakey Type I dissections in the presence of malperfusion. The AMDS is the world's first aortic arch remodeling device for use in...Read more
SAN DIEGO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. If approved, paltusotine will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist...Read more
RMAT designation recognizes the preliminary clinical evidence of the potential benefit of AAV2-hAQP1 as a one-time treatment for this debilitating condition RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, Dec. 09, 2024 (GLOBE NEWSWIRE) --...Read more
WESTON, Fla., Dec. 9, 2024 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Cantex's azeliragon for the treatment of brain metastasis from breast cancer. This new azeliragon designation adds to...Read more
First Breakthrough Therapy Designation for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan Based on TROPION-Lung05 Phase II trial and supported by data from TROPION-Lung01 Phase III trial WILMINGTON, Del. / Dec 09, 2024 / Business Wire / Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth...Read more
Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk reduction in bacterial bloodstream infections versus placebo Breakthrough Therapy meeting with FDA on next study of SER-155 in allo-HSCT expected in Q1 2025 Seres seeking SER-155 strategic partnership to accelerate next study in allo-HSCT and expand to multiple target populations CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE...Read more
Phase 1 clinical trial for OP-3136 to initiate in early 2025 SAN FRANCISCO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational...Read more
LATHAM, N.Y. / Dec 09, 2024 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NanoKnife System for prostate tissue ablation. The Company received...Read more
Decision based on NIAGARA Phase III trial results which demonstrated a statistically significant and clinically meaningful event-free and overall survival benefit If approved, this will be the first and only perioperative immunotherapy regimen in this curative-intent setting WILMINGTON, Del. / Dec 06, 2024 / Business Wire / AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) has been accepted and...Read more
Based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo WILMINGTON, Del. / Dec 05, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted...Read more
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients MANNHEIM, Germany, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to...Read more
Nanox.ARC receives additional FDA clearance to produce tomographic images for general use, including pulmonary, intra-abdominal and paranasal indications, in addition to its previously cleared indication for the musculoskeletal system Nanox.ARC uses high voltage powered digital X-ray tubes for 3D tomosynthesis imaging that could help expand availability of medical imaging Nanox.ARC now deployed at healthcare facilities across seven...Read more
Application is based on data from the Phase III STARGLO study where Columvi plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival This regimen could provide an off-the-shelf, fixed-duration treatment option for patients to start soon after diagnosis, which is important for those who are at high-risk of disease progression Improving survival outcomes is needed for...Read more
NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the United States Food and Drug Administration (FDA) has granted its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy Revascor® (rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) designation...Read more
BIZENGRI® is the first and only therapy approved by the FDA specifically for pancreatic adenocarcinoma and NSCLC that harbor NRG1 gene fusions and are advanced unresectable or metastatic1 Merus and Partner Therapeutics announced a license agreement for U.S. commercialization UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage...Read more
A Total Knee Replacement Alternative for Patients with Metal and/or Bone Cement Sensitivities WARSAW, Ind., Dec. 4, 2024 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a total knee implant component offering an alternative for patients...Read more
Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies Update on the company’s plans for a global, randomized, controlled Phase 3 registrational study anticipated by year-end BEDFORD, Mass. / Dec 04, 2024 / Business Wire / Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by...Read more
This is the second Fast Track Designation granted to LP-184 in 2024, following the designation for Glioblastoma (GBM) announced in October 2024. Fast Track Designation for LP-184 recognizes TNBC as a serious condition impacting approximately 29,000 patients annually in the US, with over 50% of patients relapsing within 3-5 years. LP-184 has demonstrated significant preclinical efficacy in TNBC models, including those resistant to PARP...Read more
REDWOOD CITY, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ersodetug for the treatment of hypoglycemia due to tumor HI. "FDA's granting of Orphan...Read more
The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile CAPLYTA, if approved as an adjunctive therapy in MDD, would be indicated for the treatment of three different major psychiatry indications affecting over 30 million adult patients in the US BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular...Read more
NORWOOD, Mass., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer. CRB-701 (SYS6002) is a next-generation antibody drug conjugate...Read more
First breakthrough therapy designation for investigational sac-TMT in the U.S. RAHWAY, N.J. / Dec 03, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung...Read more
Company's first 510(k) clearance unlocks a TAM of $40 billion in healthcare B2B opportunities PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring. The clearance enables Movano Health to pursue multi-billion dollar business opportunities for health...Read more
Fast Track designation is designed to expedite clinical development and regulatory review timelines Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases, including systemic lupus erythematosus; expect to report initial clinical data in 2025 SEATTLE, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered...Read more
QUEENSBURY, N.Y. / Dec 02, 2024 / Business Wire / Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 2, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to R289 for the treatment of patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS). R2891, Rigel's...Read more
Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis SPRING HOUSE, Pa., Dec. 2, 2024 /PRNewswire/ -- Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of children 6 years and older...Read more
PDUFA Target Action Date Set for September 26, 2025 SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The FDA assigned the...Read more
Phase 1b Study in CKD Patients to begin early 2025 SAN DIEGO / Dec 02, 2024 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the treatment of disease, announced today that the United States Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for...Read more
Designation underscores significant unmet need in frontotemporal dementia and the potential role of neflamapimod in multiple neurologic disorders On track to report topline data from the RewinD-LB Phase 2b clinical trial in early-stage dementia with Lewy bodies (DLB) in December 2024 BOSTON, Nov. 27, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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