Regulatory

Drug Development

Biopharma Update on the Novel Coronavirus: September 28

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.

September 22, 2020

2 min read

BioSpace Editorial Staff

Policy

Biopharma Update on the Novel Coronavirus: September 25

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.

September 22, 2020

4 min read

BioSpace Editorial Staff

Drug Development

Biopharma Update on the Novel Coronavirus: September 23

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.

September 22, 2020

5 min read

BioSpace Editorial Staff

Policy

FDA Accepts BLA for bluebird and BMS’ Multiple Myeloma CAR-T Treatment

Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review.

September 22, 2020

2 min read

Alex Keown

Policy

Biopharma Update on the Novel Coronavirus: September 21

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.

September 21, 2020

2 min read

BioSpace Editorial Staff

Drug Development

Biopharma Update on the Novel Coronavirus: September 18

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.

September 17, 2020

3 min read

BioSpace Editorial Staff

Policy

Orphazyme’s Rare Lipid Disorder Drug Arimoclomol Gets Priority Review from the FDA

Arimoclomol will be reviewed under Priority Review with a PDUFA date of March 17, 2021. Here’s more about it.

September 16, 2020

3 min read

Mark Terry

Policy

Biopharma Update on the Novel Coronavirus: September 16

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.

September 16, 2020

3 min read

BioSpace Editorial Staff

Policy

Biopharma Update on the Novel Coronavirus: September 14

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.

September 14, 2020

3 min read

BioSpace Editorial Staff

Policy

Biopharma Update on the Novel Coronavirus: September 11

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.

September 10, 2020

2 min read

BioSpace Editorial Staff

PRESS RELEASES

Press Releases

Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance

February 18, 2026

4 min read

Press Releases

Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)

February 18, 2026

8 min read

Press Releases

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

February 18, 2026

4 min read

Press Releases

CervoMed’s neflamapimod elected for inclusion in UK EXPERTS-ALS platform designed to prioritize promising treatments for Amyotrophic Lateral Sclerosis

February 18, 2026

10 min read

Press Releases

Helsinn announces European Commission approval of AKYNZEO® Oral Suspension

February 18, 2026

2 min read

Press Releases

FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction

February 18, 2026

8 min read

Press Releases

Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging

February 18, 2026

10 min read

Press Releases

Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older

February 17, 2026

2 min read

Press Releases

Health Canada Approves KEYTRUDA SC™, a subcutaneous formulation of pembrolizumab across multiple cancer indications

February 17, 2026

7 min read

Press Releases

Genmab Files Annual Report with the U.S. Securities and Exchange Commission - February 17, 2026

February 17, 2026

3 min read

Press Releases

FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

February 17, 2026

2 min read

Press Releases

Diakonos Oncology Announces Study to Continue after First DSMB Safety Review of DOC1021 in Phase 2 GBM Study

February 17, 2026

3 min read

Press Releases

FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

February 17, 2026

32 min read

Press Releases

FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)

February 17, 2026

13 min read

Press Releases

Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Meclizine (Generic Dramamine(R))

February 17, 2026

6 min read

Press Releases

IGC Pharma Secures North American Composition Protection for IGC-AD1 as Phase 2 CALMA Enrollment Advances

February 17, 2026

3 min read

Press Releases

Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average

February 17, 2026

4 min read

Press Releases

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL

February 17, 2026

6 min read

Press Releases

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma

February 17, 2026

6 min read

Press Releases

ImmunityBio Reports Productive Regulatory Engagement with Saudi Food and Drug Authority at USA-Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia

February 17, 2026

18 min read