Regulatory Approvals23 Apr 2026
PMV Pharmaceuticals Announces Board Chair Transition
PMV Pharmaceuticals announced a leadership transition on its Board of Directors, with Laurie Stelzer appointed as the new Chair, succeeding Rich Heyman, Ph.D....
Regulatory Approval
Regulatory Approvals
Regulatory Approvals22 Apr 2026
Cristcot Announces FDA Acceptance of NDA for Next-Generation Hydrocortisone Acetate (ngHCA) for Treatment of Ulcerative Colitis (UC) of the Rectum
Cristcot announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for next-generation hydrocortisone acetate...
Regulatory Approvals22 Apr 2026
Opinion: As Duchenne Innovation Booms, Let’s Ensure It Becomes Real Progress
Sarepta Therapeutics' President of Research & Development, Louise Rodino-Klapac, reflects on the evolving landscape of Duchenne muscular dystrophy (DMD)...
Regulatory Approvals22 Apr 2026
Replimune cuts will leave over 200 jobless in Massachusetts
Replimune announced significant layoffs affecting 224 employees across its Woburn headquarters and Framingham manufacturing site in Massachusetts. This...
Regulatory Approvals22 Apr 2026
Trump throws support behind psychedelics with executive order
President Donald Trump signed an executive order on April 20, 2026, to accelerate the development and facilitate broader access to psychedelic therapies for...
Regulatory Approvals22 Apr 2026
Orion Pharma’s ODM-212 Granted Orphan Drug Designation in Mesothelioma by the US FDA
Orion Corporation announced that its investigational drug ODM-212 received Orphan Drug Designation (ODD) from the US FDA for the treatment of mesothelioma, a...
Regulatory Approvals22 Apr 2026
Trump instructs FDA to accelerate psychedelics development
President Donald Trump issued an executive order on April 18, 2026, directing the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to psychedelic...
Regulatory Approvals03 Nov 2025
Akeso's Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast Cancer
Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Adm...
31 Oct 2025
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Regulatory Approvals31 Oct 2025
Vizient Applauds FDA Actions to Accelerate Biosimilar Development and Lower Costs
Vizient commends the FDA for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater cla...
Regulatory Approvals27 Oct 2025
FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) for Pulmonary Arterial Hypertension Based on Phase 3 ZENITH Study
Merck announced that the FDA has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) based on the Phase 3 ZENITH trial. The...
Regulatory Approvals20 Oct 2025
FDA Approves Genentech's Gazyva for Lupus Nephritis Treatment
The FDA has approved Genentech's Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis (LN) receiving standard therapy. The ap...
Regulatory Approvals17 Oct 2025
OS Therapies Receives FDA and MHRA Feedback on OST-HER2 for Metastatic Osteosarcoma
OS Therapies Inc. announced that the FDA granted a Type C meeting to discuss clinical efficacy data endpoints for a BLA under the Accelerated Approval...
Regulatory Approvals16 Oct 2025
Civica to Launch Affordable Long-Acting Insulin Glargine in the US
Non-profit pharmaceutical company Civica is set to launch a long-acting insulin, insulin glargine-yfgn, in pre-filled pens at the lowest list price in...
Regulatory Approvals14 Oct 2025
Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCC
Bicara Therapeutics announced that the FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for...
Regulatory Approvals14 Oct 2025
MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes Patients
MannKind Corporation announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Afrezza (insulin human) Inhalation ...
Regulatory Approvals14 Oct 2025
Palisade Bio Receives Canadian Patent for PALI-2108 Composition
Palisade Bio announced that the Canadian Intellectual Property Office has granted patent number 3,174,137 for the composition of PALI-2108, its orally...
Regulatory Approvals09 Oct 2025
FDA Approves Boehringer Ingelheim's Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis
The U.S. FDA has approved Boehringer Ingelheim's JASCAYD® (nerandomilast) tablets as the first new treatment option in over a decade for adults with I...
Regulatory Approvals07 Oct 2025
Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Tralesinidase Alfa for Sanfilippo Syndrome Type B
Spruce Biosciences received Breakthrough Therapy Designation from the FDA for tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment...
Regulatory Approvals06 Oct 2025
Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for Cognitive Impairment Associated with Schizophrenia
Alto Neuroscience received FDA Fast Track designation for ALTO-101 for treating cognitive impairment associated with schizophrenia (CIAS). ALTO-101, a...
Regulatory Approvals06 Oct 2025
Cellectar Biosciences Announces EMA Eligibility for Conditional Marketing Authorization of Iopofosine I 131 for Refractory Waldenstrom Macroglobulinemia
Cellectar Biosciences announced that the European Medicines Agency (EMA) has confirmed the eligibility to file for Conditional Marketing Authorization...
Regulatory Approvals02 Oct 2025
AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450
AEON Biopharma announced that the FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 (prabotulinumtoxinA)...
Regulatory Approvals02 Oct 2025
Vanda Pharmaceuticals Announces Collaborative Framework with FDA for Dispute Resolution
Vanda Pharmaceuticals and the FDA have agreed on a collaborative framework to resolve disputes regarding HETLIOZ® (tasimelteon) and tradipitant. The F...
Regulatory Approvals30 Sept 2025
Kedrion Biopharma Receives FDA Approval for QIVIGY for Primary Humoral Immunodeficiency
Kedrion Biopharma announced FDA approval for QIVIGY (Immune Globulin 10% IV) for treating adults with primary humoral immunodeficiency (PI). QIVIGY, a...
Regulatory Approvals24 Sept 2025
Noul Receives FDA Registration for Cervical Cancer Diagnostic Cartridge
Noul Co., Ltd. has secured FDA registration for its miLab™ Cartridge CER and SafeFix™ CER, essential components of its miLab™ CER cervical cancer diag...
Regulatory Approvals24 Sept 2025
Biogen Receives Complete Response Letter from FDA for High Dose Nusinersen in Spinal Muscular Atrophy
Biogen announced that the FDA issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for a high dose regimen of nusi...
Regulatory Approvals19 Sept 2025
Innovent's Mazdutide Approved in China for Glycemic Control in Type 2 Diabetes
Innovent Biologics announced that China's NMPA has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor a...
Regulatory Approvals18 Sept 2025
Biocon Biologics Receives FDA Approval for Denosumab Biosimilars Bosaya and Aukelso
Biocon Biologics Ltd. (BBL) announced that the U.S. FDA has approved Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq), biosimilars of Prolia® an...
Regulatory Approvals09 Sept 2025
Saol Therapeutics Receives FDA Complete Response Letter for SL1009 (DCA) for Pyruvate Dehydrogenase Complex Deficiency
Saol Therapeutics announced that the FDA issued a Complete Response Letter (CRL) for their New Drug Application (NDA) of SL1009 (Sodium Dichloroacetat...
Regulatory Approvals04 Sept 2025
Olomorasib Receives FDA Breakthrough Therapy Designation for KRAS G12C-Mutant Lung Cancer
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combin...
Regulatory Approvals04 Sept 2025
C4 Therapeutics' Partner Biogen Receives FDA IND Acceptance for IRAK4 Degrader BIIB142
C4 Therapeutics announced that its partner, Biogen, received FDA IND acceptance for BIIB142, an IRAK4 degrader. BIIB142 is intended for the treatment...
Regulatory Approvals04 Sept 2025
Agios Pharmaceuticals Announces PDUFA Date Extension for PYRUKYND® in Thalassemia
Agios Pharmaceuticals announced a three-month extension to the FDA's Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Ap...
Regulatory Approvals02 Sept 2025
FDA Approves BILDYOS® and BILPREVDA®, Biosimilars to PROLIA and XGEVA
The US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to PROLIA and XGEVA, res...
Regulatory Approvals02 Sept 2025
FDA Accepts Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilars
Professor Sarfaraz K. Niazi secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars. This...
Regulatory Approvals01 Sept 2025
Abbott's Navitor TAVI System Receives CE Mark for Expanded Aortic Stenosis Indication
Abbott announced that its Navitor transcatheter aortic valve implantation (TAVI) system received CE Mark approval in Europe for an expanded indication...
Regulatory Approvals01 Sept 2025
Boehringer Ingelheim's HERNEXEOS® Approved in China for HER2-Mutant NSCLC
Boehringer Ingelheim announced the approval of HERNEXEOS® (zongertinib) by China's NMPA for treating adult patients with unresectable, locally advance...
Regulatory Approvals29 Aug 2025
Teva Launches First Generic GLP-1 for Weight Loss: Liraglutide Injection
Teva Pharmaceuticals announced the FDA approval and US launch of its generic version of Saxenda® (liraglutide injection), the first generic glucagon-l...
Regulatory Approvals29 Aug 2025
Vanda Pharmaceuticals' VGT-1849B Receives Orphan Drug Designation for Polycythemia Vera
Vanda Pharmaceuticals announced that the FDA granted Orphan Drug Designation to VGT-1849B, a selective JAK2 inhibitor for treating polycythemia vera (...
Regulatory Approvals25 Aug 2025
FDA Suspends License for Valneva's Chikungunya Vaccine IXCHIQ®
Valneva announced that the FDA has suspended the license for its chikungunya vaccine, IXCHIQ®, due to four new reports of serious adverse events (SAEs...
Regulatory Approvals25 Aug 2025
Avenacy Launches Lidocaine Hydrochloride Injection in the U.S.
Avenacy, a specialty pharmaceutical company, announced the launch of its Lidocaine Hydrochloride Injection, USP, in the United States. This is Avenacy...