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HBW Insight
Questions For FDA On OTC Switches, Alternative Tests And Budget Cuts At OMUFA Hearing
19 Jul 2025 • By Malcolm Spicer
With the clock ticking on the US Food and Drug Administration OTC monograph drug user ...
HBW Insight
US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens
19 Jul 2025 • By Lauren Nardella
The US Food and Drug Administration says animal tests are the only viable option right ...
Pink Sheet
Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In ...
19 Jul 2025 • By Bridget Silverman
Where talk of regulatory flexibility is common in contested approval decisions, the US Food and ...
Companies
Idex Corp.
19 Jul 2025 • By
http://www.idexcorp.com
Companies
DiethelmKellerSiberHegner
19 Jul 2025 • By
https://www.dksh.com/global-en/home/healthcare
Companies
Shilpa Biologicals
19 Jul 2025 • By
https://www.shilpabio.com/
Companies
Melio Bio Limited
19 Jul 2025 • By
https://melio.bio/
Companies
Bojiyuan (Shanghai) Biomedical Co., Ltd.
19 Jul 2025 • By
Companies
Quetzal Therapeutics LLC
19 Jul 2025 • By
Companies
Jiangsu ProteLight Pharmaceutical & Biotechnology Co Ltd
19 Jul 2025 • By
http://www.protelight.com
Companies
Huiankai (Xiamen) Pharmaceutical Technology Co.,Ltd.
19 Jul 2025 • By
Companies
Sanofi
19 Jul 2025 • By
https://www.sanofi.com/en
Companies
NanoVibronix, Inc.
19 Jul 2025 • By
http://www.nanovibronix.com/
Companies
VERAXA Biotech GmbH
19 Jul 2025 • By
https://www.veraxa.com/
Pink Sheet
Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector
18 Jul 2025 • By Mandy Jackson
Sarepta Therapeutics refused a US Food and Drug Administration request to voluntarily stop all shipments ...
Scrip
FDA Asked, Sarepta Refused To Stop Elevidys Shipments After Third Death With Gene Therapy Vector
18 Jul 2025 • By Mandy Jackson
Sarepta Therapeutics’ transparency is in question after reports emerged of a patient death in a ...
Scrip
Genentech Gets Columvi Complete Response Following ODAC’s No
18 Jul 2025 • By Joseph Haas
Roche affiliate Genentech revealed on July 18 that the US Food and Drug Administration denied ...
Pink Sheet
Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands
18 Jul 2025 • By Cathy Kelly
Upcoming federal spending reductions and resulting coverage losses in Medicaid could have a significant impact ...
Medtech Insight
Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out
18 Jul 2025 • By Elizabeth Orr
Many medical device sterilization plants will get an extra two years to comply with the ...
Scrip
BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia
18 Jul 2025 • By Alaric DeArment
Bristol Myers Squibb is hopeful that it still has a chance to expand the label ...