americapharmatoday.bsky.social
LightNews LightNews
banner
americapharmatoday.bsky.social
americapharmatoday.bsky.social
@americapharmatoday.bsky.social
1 followers 1 following 19 posts
Posts Replies Media Videos
americapharmatoday.bsky.social
FDA approved Tukysa maintenance after HER2-positive induction. Median PFS 24.9 vs 16.3 months. Overall survival was immature.

https://americapharmatoday.com/news/fda-approves-tukysa-maintenance-her2-breast-cancer?utm_source=bluesky&utm_medium=social&utm_campaign=tukysa-maintenance-20261007

#FDA
FDA approves Tukysa maintenance for HER2-positive disease — America Pharma Today
FDA approved Tukysa with trastuzumab and pertuzumab as maintenance after induction. Median PFS was 24.9 versus 16.3 months. Survival data were immature.
americapharmatoday.com
October 8, 2026 at 1:48 PM
americapharmatoday.bsky.social
Infigratinib NDA accepted for achondroplasia. Priority review. PDUFA 4 Feb 2027. Not an approval.
https://americapharmatoday.com/news/bridgebio-infigratinib-nda-priority-review-achondroplasia?utm_source=bluesky&utm_medium=social&utm_campaign=bridgebio-infigratinib-nda-priority-review-achondroplasia
FDA accepted oral infigratinib; decision due 4 Feb 2027 — America Pharma Today
FDA accepted BridgeBio’s infigratinib NDA for children with achondroplasia and granted priority review. The PDUFA date is 4 February 2027. Not an approval.
americapharmatoday.com
October 7, 2026 at 3:47 PM
americapharmatoday.bsky.social
FDA opened comments on early ibogaine trial design. Docket FDA-2026-N-10429 closes 20 Nov. Not an approval.

https://americapharmatoday.com/news/fda-ibogaine-early-trial-design-comment-request?utm_source=bluesky&utm_medium=social&utm_campaign=fda-ibogaine-rfi-20261005

#FDA
FDA opens comments on early ibogaine trial design — America Pharma Today
FDA wants comment by 20 November on early ibogaine trial design, including a proposed starting dose at or below 10 mg/kg. Not an approval.
americapharmatoday.com
October 6, 2026 at 12:33 PM
americapharmatoday.bsky.social
Cullinan started an FDA RTOR filing for first-line zipalertinib plus chemo. Not an approval.

https://americapharmatoday.com/news/cullinan-zipalertinib-rtor-filing-egfr-exon20?utm_source=bluesky&utm_medium=social&utm_campaign=cullinan-zipalertinib-rtor-filing-egfr-exon20

#FDA
Cullinan starts FDA RTOR filing for zipalertinib — America Pharma Today
Cullinan has started an FDA real-time review filing for zipalertinib plus chemotherapy. The submission is not complete and not an approval.
americapharmatoday.com
October 4, 2026 at 1:29 PM
americapharmatoday.bsky.social
FDA approved Jaypirca on 2 Oct for untreated CLL/SLL with no known 17p deletion. PFS hazard ratio 0.20. Survival follow-up is immature.

https://americapharmatoday.com/news/fda-approves-jaypirca-untreated-cll-sll?utm_source=bluesky&utm_medium=social&utm_campaign=jaypirca-untreated-cll-20261002
FDA approves Jaypirca for untreated CLL without 17p — America Pharma Today
FDA approved Jaypirca for previously untreated CLL or SLL with no known 17p deletion. Survival follow-up is still immature.
americapharmatoday.com
October 3, 2026 at 2:54 PM
americapharmatoday.bsky.social
FDA approved a pulmonary valve that starts near 13 mm and can widen to 22 mm. 62 children, 12 US sites. Device PMA, not a drug approval.
https://americapharmatoday.com/news/fda-approves-autus-size-adjustable-pulmonary-valve?utm_source=bluesky&utm_medium=social&utm_campaign=autus-valve-pma-20261001
FDA approves a pulmonary valve that can grow with a child — America Pharma Today
FDA approved the Autus pulmonary valve, which can be balloon-widened as a child grows. It is a device approval, not a drug approval.
americapharmatoday.com
October 2, 2026 at 6:48 PM
americapharmatoday.bsky.social
FDA approved Camzyos for pediatric obstructive HCM (≥30 kg). First for that use. Boxed warning and REMS still apply.

https://americapharmatoday.com/news/fda-approves-camzyos-pediatric-obstructive-hcm?utm_source=bluesky&utm_medium=social&utm_campaign=fda-approves-camzyos-pediatric-obstructive-hcm
FDA approves Camzyos for children with obstructive HCM — America Pharma Today
FDA approved Camzyos for children with symptomatic obstructive HCM who weigh at least 30 kg. The heart-failure boxed warning and REMS still apply.
americapharmatoday.com
October 1, 2026 at 6:21 PM
americapharmatoday.bsky.social
FDA: charges over alleged counterfeit Ozempic. An indictment is not a conviction or a recall.

https://americapharmatoday.com/news/fda-charges-alleged-counterfeit-ozempic-scheme?utm_source=bluesky&utm_medium=social&utm_campaign=counterfeit-ozempic-charges-20260929

#FDA
FDA: charges in alleged counterfeit Ozempic case — America Pharma Today
FDA said two men were charged over alleged counterfeit Ozempic sold in the US. An indictment is not a conviction or a recall.
americapharmatoday.com
September 30, 2026 at 1:53 PM
americapharmatoday.bsky.social
FDA approved Emcitate (tiratricol) 28 Sep for MCT8 deficiency — first therapy approved for this use. Not a coverage decision.
https://americapharmatoday.com/news/fda-approves-emcitate-tiratricol-mct8?utm_source=bluesky&utm_medium=social&utm_campaign=emcitate-mct8-20260928
#FDA
FDA approves Emcitate for MCT8 deficiency — America Pharma Today
FDA approved Emcitate (tiratricol) on 28 Sep 2026 for peripheral thyrotoxicosis in MCT8 deficiency. First approved therapy for this use.
americapharmatoday.com
September 29, 2026 at 2:15 PM
americapharmatoday.bsky.social
FDA lists Juvmo (tavapadon), approved 25 Sep for Parkinson’s in adults. Not a coverage decision.

https://americapharmatoday.com/news/fda-approves-juvmo-tavapadon-parkinsons?utm_source=bluesky&utm_medium=social&utm_campaign=fda-approves-juvmo-tavapadon-parkinsons

#FDA
FDA lists Juvmo approval for Parkinson’s — America Pharma Today
FDA’s 2026 novel-drug table lists Juvmo (tavapadon), approved 25 Sep for Parkinson’s disease in adults. AbbVie reported TEMPO results.
americapharmatoday.com
September 28, 2026 at 7:31 PM
americapharmatoday.bsky.social
HHS asked if deceased-donor islets stay FDA biologics or become organs under OPTN. Comments due 9 Nov. Lantidra unchanged.
https://americapharmatoday.com/news/hhs-rfi-deceased-donor-islet-cells-type-1-diabetes?utm_source=bluesky&utm_medium=social&utm_campaign=hhs-islet-rfi-20260924
#FDA
HHS opens a docket on deceased-donor islets — America Pharma Today
HHS asked for comment by 9 Nov 2026 on how to regulate deceased-donor islet cells for type 1 diabetes. Lantidra’s FDA license is unchanged.
americapharmatoday.com
September 27, 2026 at 3:40 PM
americapharmatoday.bsky.social
FDA set a 26 Oct meeting on proposed BsUFA IV fees (FY2028–2032). Comments close 25 Nov. Authority expires Sept 2027.
https://americapharmatoday.com/news/fda-bsufa-iv-reauthorization-public-meeting-october-26-2026?utm_source=bluesky&utm_medium=social&utm_campaign=bsufa-iv-meeting-20261026
#FDA
FDA sets Oct. 26 meeting on BsUFA IV fees — America Pharma Today
FDA will hold a 26 Oct 2026 public meeting on proposed BsUFA IV recommendations for FY2028–2032. Comments close 25 Nov. Authority expires Sept 2027.
americapharmatoday.com
September 27, 2026 at 3:40 PM
americapharmatoday.bsky.social
FDA approved Amneal lanreotide (ANDA 218217) on 18 Sep. TE code AB. Reference: Somatuline Depot. CGT first marketing: 21 Sep.
https://americapharmatoday.com/news/fda-amneal-lanreotide-cgt-approval-somatuline?utm_source=bluesky&utm_medium=social&utm_campaign=amneal-lanreotide-cgt-20260918
#FDA
FDA approves Amneal lanreotide as a CGT generic — America Pharma Today
FDA approved Amneal lanreotide injection, ANDA 218217, on 18 Sep 2026 with TE code AB. First marketing date on the CGT list is 21 Sep.
americapharmatoday.com
September 27, 2026 at 3:40 PM
americapharmatoday.bsky.social
FDA approved Gazyva on 25 Sep to cut relapse risk in childhood nephrotic syndrome (age 2+, in remission). Boxed warning: hep B and PML.

https://americapharmatoday.com/news/fda-approves-gazyva-idiopathic-nephrotic-syndrome?utm_source=bluesky&utm_medium=social&utm_campaign=gazyva-ins-20260925

#FDA
FDA approves Gazyva for nephrotic syndrome relapse — America Pharma Today
FDA approved Gazyva on 25 Sep 2026 to reduce relapse in childhood-onset idiopathic nephrotic syndrome. The label has a boxed warning.
americapharmatoday.com
September 26, 2026 at 7:24 PM
americapharmatoday.bsky.social
FDA approved Atebrioz (zilurgisertib) on 25 Sep for FOP. Week 24 new bone: -3.2 cm3 on drug, +24.6 cm3 on placebo. Not coverage.

https://americapharmatoday.com/news/fda-approves-atebrioz-zilurgisertib-fop?utm_source=bluesky&utm_medium=social&utm_campaign=atebrioz-fop-20260925

#FDA
FDA approves Atebrioz for FOP bone formation — America Pharma Today
FDA approved Atebrioz (zilurgisertib) on 25 Sep 2026 to reduce new heterotopic bone in FOP. Week-24 volume fell on drug and rose on placebo.
americapharmatoday.com
September 26, 2026 at 7:24 PM
americapharmatoday.bsky.social
Symptomatic severe TAVR no longer needs a Medicare CED study. Asymptomatic cases still do. Regurgitation is open.

https://americapharmatoday.com/news/cms-tavr-medicare-coverage-symptomatic-ced-ends?utm_source=bluesky&utm_medium=social&utm_campaign=cms-tavr-medicare-coverage-symptomatic-ced-ends
CMS ends CED for symptomatic Medicare TAVR — America Pharma Today
Medicare will cover symptomatic severe TAVR without a CED study. Asymptomatic severe stenosis stays inside a CMS-approved study.
americapharmatoday.com
September 25, 2026 at 5:39 PM
americapharmatoday.bsky.social
FDA approved Onswik on 24 Sep: once-weekly insulin for adults with type 2. Not for type 1. Approval is not coverage.
https://americapharmatoday.com/news/fda-approves-onswik-once-weekly-insulin-type-2?utm_source=bluesky&utm_medium=social&utm_campaign=onswik-weekly-insulin-20260924
FDA approves once-weekly insulin Onswik for type 2 — America Pharma Today
FDA approved Onswik on 24 Sep 2026, a once-weekly insulin for adults with type 2 diabetes. Not recommended for type 1. Not a coverage decision.
americapharmatoday.com
September 24, 2026 at 3:41 PM
americapharmatoday.bsky.social
Boxed warning ≠ withdrawal. FDA upgraded Injectafer for low phosphate; the IV iron stays approved.

https://americapharmatoday.com/news/fda-injectafer-boxed-warning-hypophosphatemia?utm_source=bluesky&utm_medium=social&utm_campaign=fda-injectafer-boxed-warning-hypophosphatemia
#FDA
FDA boxed warning: Injectafer hypophosphatemia — America Pharma Today
FDA 1 Sep 2026 adds a boxed warning to Injectafer for symptomatic hypophosphatemia and repeat-course phosphate checks.
americapharmatoday.com
September 21, 2026 at 7:30 PM
americapharmatoday.bsky.social
CDRH genetics panel votes 23 Sep on GRAIL’s Galleri PMA. AdCom advice is not FDA approval.

https://americapharmatoday.com/news/fda-adcom-grail-galleri-pma-september-23-2026?utm_source=bluesky&utm_medium=social&utm_campaign=fda-adcom-grail-galleri-pma-september-23-2026
September 17, 2026 at 5:36 PM