Cingulate Receives Complete Response Letter from FDA for CTx-1301
No Clinical Safety or Efficacy Concerns Currently Identified
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AKK PROBIO Becomes the First Gut-Derived Akkermansia muciniphila to Complete FDA NDI Notification
Milestone follows 2024 dual self-affirmed GRAS certification, creating a comprehensive regulatory framework for both food and dietary supplement applications in...
FDA Issues 'Surprising Series of Alerts' on Sex-Themed Sweets
Sweets billed as bedroom boosters are getting pulled from shelves for their eyebrow-raising potency. Wired notes a "surprising series of alerts" from the F...
Herantis reports positive FDA feedback and finalizes Phase 2a study design for HER-096
FDA considered the planned HER-096 Phase 2a study design appropriateStudy design finalized; approximately 100 patients to be enrolledMore than 50% of Phase 2 fu...
FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting
Filing acceptance, under priority review, based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared ...
Fulcrum Therapeutics Announces Discontinuation of Pociredir Program in Sickle Cell Disease and Initiation of Strategic Review
― Decision follows FDA feedback regarding the implications of the secondary malignancies observed with Tazverik®(tazemetostat) and the product’s subsequent...
REPL Stock Soars on Plans of BLA Resubmission for Melanoma Combo Drug
Replimune stock surges after the company aligned with the FDA on plans to resubmit its BLA for RP1 plus Opdivo in advanced melanoma.
Merck's Calderasib Gets FDA's Breakthrough Therapy Tag for NSCLC
MRK wins FDA Breakthrough Therapy designation for calderasib plus Keytruda for certain newly diagnosed metastatic KRAS G12C-mutant NSCLC patients.
FDA Ousts Another Top Official: Who’s Behind the Shakeup — and Why?
The recent FDA leadership shakeup has stirred controversy with the dismissal of Tracy Beth Høeg. Learn more about the fallout.
ADMA Biologics (ADMA) Receives FDA Label Expansion for ASCENIV
ADMA Biologics Inc. (NASDAQ:ADMA) is one of the best cheap stocks under $10 to buy in June. On May 4, ADMA Biologics received FDA approval to expand the label f...
‘Sexual Chocolate’ Faces Recalls After FDA Tests Reveal Undisclosed Viagra
Sellers of products with names like Boner Bears and DTF have voluntarily recalled their products after testing positive for the active ingredients in Viagra and...
Jyong Biotech CEO Outlines FDA Pathway and Global Strategy in PharmaBoardroom Live Interview
TAIPEI, June 1, 2026 /PRNewswire/ -- Jyong Biotech Ltd. (Nasdaq: MENS) (the 'Company' or 'Jyong Biotech'), a science-driven biotechnology company dedicated to t...
In Trial, Pill Doubles Pancreatic Cancer Survival
A pill that's been in the works since the Carter administration has changed the math on one of the deadliest cancers. In a study of 500 people with advanced pan...
This Week in Science: A Sleep Apnea Pill, Ancient Anesthetic, And More!
This Week In Science: A sleep apnea pill has been fast-tracked for FDA approval; the earliest evidence of surgical anesthetic detected on tools from more than 6...
Trump’s FDA Course Correction Is a Win for Consumers
Trump’s FDA reforms boost consumer access to safer vaping and natural 7-OH products with better regulation.
Patients, doctors hail 'revolutionary' new drug for pancreatic cancer
The FDA has given some patients early access to the drug, daraxonrasib, as it nears regulatory approval. It's the first treatment to considerably extend the liv...
Replimune Shares Surge 82% After FDA Aligns On RP1 Melanoma Filing Path
Replimune Group, Inc. (REPL) shares soared 82.34 percent to $8.54, up $3.86 on Friday, after the biotechnology company announced progress with the U.S. Food and...
FDA Recalls Boner Bears ‘Sex Chocolate’ Over Undeclared ‘Viagra’ Ingredient
FDA found Viagra's active drug in Boner Bears Sex Chocolate. Maker JXK Enterprises issued a nationwide recall three months after the agency flagged the product.
Planned Parenthood thumbs nose at FDA by selling abortion pills to women before they’re pregnant
Planned Parenthood has begun prescribing abortion pills to women before they get pregnant, defying the Food and Drug Administration's safety protocol and height...
FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test
FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test