#Biotechnology #FDAApproval #ClinicalTrials
www.nasdaq.com
Weekly Buzz: GSK's Lynavoy Gets FDA Nod; Reproxalap Rejected Again; LNSR Ends Merger Deal
(RTTNews) - This week's biotech landscape witnessed key FDA approvals, rejections, NDA resubmissions, merger terminations, trial discontinuations, and clinical trial data readouts across therapeutic areas such as Turner Syndrome, Late-Line Colorectal Cancer, Obesity, and Type 1 Diabetes.
#RareDiseases #MPS #FDAApproval
www.newsweek.com
Moms stage "funeral" outside FDA in drug protest
More than 100 mothers and advocates affected by a type of rare disease gathered outside the Food and Drug Administration (FDA) on Wednesday to stage a funeral to "mourn the futures" of their children, following the agency's rejections of various rare disease treatments.
#RareDiseases #FDAApproval #PatientAdvocacy
www.newsweek.com
Mothers "terrified" as children could lose treatments after FDA denials
Mothers from across the country have spoken to Newsweek about their concern for their children after the Food and Drug Administration (FDA) has been rejecting various treatments for rare diseases that can be life-threatening.
#ObesityTreatment #WeightLoss #FDAApproval
www.yahoo.com
FDA approves Allurion's PMA application for Gastric Balloon System
Allurion's founder and CEO Dr Shantanu Gaur stated that the Smart Capsule offers a safe and effective alternative to GLP-1s and bariatric surgery, aiming to provide metabolically healthy weight loss and become a standard tool in obesity treatment in the US.
#Moderna #FluVaccine #FDAApproval
www.nbcnews.com
FDA reverses course, will review Moderna's mRNA flu vaccine
Moderna said on Wednesday the U. S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modifications.
#DepressionTreatment #FDAApproval #Pharmaceuticals
www.benzinga.com
Why Is GH Research Stock Soaring Monday? - GH Research (NASDAQ:GHRS)
The U. S. Food and Drug Administration (FDA) on Monday lifted the clinical hold on GH Research Plc's (NASDAQ:GHRS) Investigational New Drug Application (IND) for GH001.
#Biopharmaceuticals #LiverDisease #FDAApproval
www.benzinga.com
Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH - Altimmune (NASDAQ:ALT)
GAITHERSBURG, Md. , Jan. 05, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (NASDAQ:ALT), a late clinical-stage biopharmaceutical company developing therapies that address serious liver diseases, today announced the U.
#MultipleSclerosis #FDAApproval #GenericDrugs
www.nasdaq.com
ScinoPharm Wins First FDA Approval With Glatiramer Acetate Injection For Multiple Sclerosis
(RTTNews) - ScinoPharm Taiwan (TWSE: 1789) today announced that the U. S. FDA has approved its Glatiramer Acetate Injection, a generic version of Teva's Copaxone, for the treatment of adult patients with multiple sclerosis.
#Type1Diabetes #Sanofi #FDAApproval
www.benzinga.com
Press Release: Sanofi's Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
Enter your email to get Benzinga's ultimate morning update: The PreMarket Activity Newsletter
Sanofi's Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
If approved, Tzield would be the first disease-modifying therapy to delay the onset of stage 3 T1D in children aged one and older diagnosed with stage 2 T1DTzield slows disease progression by protecting the insulin-secreting beta cells of the pancreasThe priority review is based on interim results from the PETITE-T1D phase 4 study
Paris, January 5, 2026.
#Type1Diabetes #Sanofi #FDAApproval
www.benzinga.com
Press Release: Sanofi's Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
Enter your email to get Benzinga's ultimate morning update: The PreMarket Activity Newsletter
Sanofi's Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
If approved, Tzield would be the first disease-modifying therapy to delay the onset of stage 3 T1D in children aged one and older diagnosed with stage 2 T1DTzield slows disease progression by protecting the insulin-secreting beta cells of the pancreasThe priority review is based on interim results from the PETITE-T1D phase 4 study
Paris, January 5, 2026.
#Pharmaceuticals #MultipleSclerosis #FDAApproval
www.barchart.com
ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis
All information and data in this article is solely for informational purposes. For more information please view the Barchart Disclosure Policy here
TAINAN , Jan.
#Biotech #Pharmaceuticals #FDAApproval
seekingalpha.com
Corcept Therapeutics: Despite FDA Blind Side, Relacorilant Remains A Viable Drug (NASDAQ:CORT)
CORT's strong balance sheet enables pursuit of additional clinical evidence to address the FDA's concerns and potentially secure Relacorilant approval.
